Director, Quality Product Strategy (Small Molecule)
MSD, Rahway, NJ, United States
Job Description
Director, Quality Product Strategy (Small Molecule) supports the end-to-end pharmaceutical product strategy in our manufacturing and testing network. Ensures development and execution of a robust quality strategy for products supporting launch of the pipeline and/or uninterrupted supply of commercial products.
Scope of responsibilities includes value chain management team (VCMT) member, franchise support of late stage pipeline quality activities as well as inline quality-related issues, sponsored project support and strategic network changes (e.g. expansion and supply chain robustness) for our inline portfolio, coordination with the Development and Commercialization Team (DCT) and Quality Working Group Leader.
Primary Activities
Leads development and oversight of the Product Quality Strategic elements for the pharmaceutical franchises that includes short- and long-term goals for the product franchise in alignment with the DCT/VCMT/Platform Councils/Product Councils. Strategic elements include inspection and launch readiness for pipeline products and testing and quality strategies (product analytical strategy), risk mitigation, issue resolution, network expansion, and supply chain robustness at the global franchise level. Acts as a quality designee for global product quality as needed.
Ensures prioritization, progress, and escalation, as appropriate, of quality-related strategic goals (including strategy, efficiency and compliance items) through periodic reviews and dashboard across products and manufacturing/testing sites across the network. Leads and/or participates in executing the VCMT/DCT aligned strategic goals with stakeholders and partners across our Research & Development Division and our Manufacturing Division.
Reviews and approves, as appropriate, franchise-level documentation including but not limited to Comparability Plans, CPV plans, Sister Site Evaluations, Post Marketing Product Reviews, Annual Management Review, Control Strategies, franchise-level protocols/reports, filing/license submissions, franchise-level regulatory observation responses, RTQs, franchise-level change control, site and multi-site investigations, where appropriate.
Leads/coordinates Quality Working Group meeting for the franchise, where applicable, and serves as the Quality Representative to DCT/VCMT and associated working groups. Collaborates with Quality leads to resolve supply chain quality issues.
Collaborates with QMS Chapter leads and document owners to define, refine, and standardize quality requirements. Identifies any gaps in QMS requirements that are critical to ensure consistent interpretation of regulations as it relates to products to drive standardization and continuous improvement of QMS documents. Tracks metrics (change control, complaint, etc.) for the franchise.
Evaluates the franchise's Annual Product Review for supply chain trends and escalates risks as necessary. Actively participates and escalates issues/risk to the Quality sponsors and via IRM as required and identifies need for and supports development of Analytical Siting decisions. Monitors and mitigates franchise Quality risks.
Participates in inspections as required and champions Permanent Inspection Readiness (PIR) for the product program.
Education & Skills Requirements
Bachelor’s Degree (BA/BS) with a concentration in Sciences or Logistics, with a minimum of twelve (12) years of experience including quality oversight roles such as technical elements or technical operations roles.
Minimum of 2 years of direct experience with supply chain strategy or technical elements (e.g. change controls, investigations, process documentation such as protocols, CPV, etc.), preferably with small molecule products.
Demonstrated skills for external-facing communications in written and verbal form.
Demonstrated success leading multi-functional teams driving continuous improvement and execution of strategic actions across a network (i.e. multiple groups/sites/functions). Travel is approximately 10%.
Entrepreneurship/Innovation – Meeting patient, customer, and organization’s needs by confronting difficult issues, offering creative alternatives, and taking action.
Decision Making/Influence – Identifying and understanding problems; gathering, analyzing, and interpreting information, establishing decision criteria, and identifying alternatives. Makes timely decisions using effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes.
Growth/Development/Change – Using new knowledge and skills on the job and learning through application. Modifying behavior based on self-awareness to improve impact and adaptability for major changes in work or environment (e.g., people, processes, structure or culture), trying new approaches.
Networking/Inclusion – Building partnerships; developing and leveraging relationships within and across work groups to achieve results. Working effectively across cultures, interpersonal styles, perspectives, motivations or backgrounds.
Execution Excellence/Ownership/Inspiration – Being proactive and setting high standards of performance for self and others; completing assignments or tasks; communicating effectively, clearly, and concisely to help stakeholders understand and retain the message; listening actively.
Required Skills
Active Pharmaceutical Ingredients (API)
Collaboration
Drug Product Manufacturing
Packaging
Pharmaceutical Drugs
Pharmaceutical Products
Product Quality
Product Quality Assurance
Quality Oversight
Small Molecule Drug Development
Small Molecule Drugs
Small Molecules
US and Puerto Rico Residents Only
Current employees apply to the role through the internal portal. Current contingent workers apply through the external portal.
We are committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please let us know if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the EEOC Know Your Rights and EEOC GINA Supplement. Learn more about your rights, including under California, Colorado and other U.S. State Acts.
U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions in the U.S. will be working a hybrid model consisting of three total days on-site per week, Monday through Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day unless business-critical tasks require an on-site presence. This model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work is performed at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. This guidance also does not apply to roles designated as “remote.”
Salary range for this role: $173,200.00 – $272,600.00. The successful candidate will be eligible for an annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, other insurance benefits for employee and family, retirement benefits, 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
Apply for this role through https://jobs.merck.com/us/en/ or via the Workday Jobs Hub if you are a current employee. The application deadline for this position is stated on this posting.
San Francisco Residents Only – We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
Los Angeles Residents Only – We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Search firm representatives: Merck & Co., Inc. does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms without a valid written agreement will be deemed the sole property of our company. No fee will be paid if a candidate is hired as a result of an agency referral without a pre-existing agreement.
Requisition ID: R390605
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Scope of responsibilities includes value chain management team (VCMT) member, franchise support of late stage pipeline quality activities as well as inline quality-related issues, sponsored project support and strategic network changes (e.g. expansion and supply chain robustness) for our inline portfolio, coordination with the Development and Commercialization Team (DCT) and Quality Working Group Leader.
Primary Activities
Leads development and oversight of the Product Quality Strategic elements for the pharmaceutical franchises that includes short- and long-term goals for the product franchise in alignment with the DCT/VCMT/Platform Councils/Product Councils. Strategic elements include inspection and launch readiness for pipeline products and testing and quality strategies (product analytical strategy), risk mitigation, issue resolution, network expansion, and supply chain robustness at the global franchise level. Acts as a quality designee for global product quality as needed.
Ensures prioritization, progress, and escalation, as appropriate, of quality-related strategic goals (including strategy, efficiency and compliance items) through periodic reviews and dashboard across products and manufacturing/testing sites across the network. Leads and/or participates in executing the VCMT/DCT aligned strategic goals with stakeholders and partners across our Research & Development Division and our Manufacturing Division.
Reviews and approves, as appropriate, franchise-level documentation including but not limited to Comparability Plans, CPV plans, Sister Site Evaluations, Post Marketing Product Reviews, Annual Management Review, Control Strategies, franchise-level protocols/reports, filing/license submissions, franchise-level regulatory observation responses, RTQs, franchise-level change control, site and multi-site investigations, where appropriate.
Leads/coordinates Quality Working Group meeting for the franchise, where applicable, and serves as the Quality Representative to DCT/VCMT and associated working groups. Collaborates with Quality leads to resolve supply chain quality issues.
Collaborates with QMS Chapter leads and document owners to define, refine, and standardize quality requirements. Identifies any gaps in QMS requirements that are critical to ensure consistent interpretation of regulations as it relates to products to drive standardization and continuous improvement of QMS documents. Tracks metrics (change control, complaint, etc.) for the franchise.
Evaluates the franchise's Annual Product Review for supply chain trends and escalates risks as necessary. Actively participates and escalates issues/risk to the Quality sponsors and via IRM as required and identifies need for and supports development of Analytical Siting decisions. Monitors and mitigates franchise Quality risks.
Participates in inspections as required and champions Permanent Inspection Readiness (PIR) for the product program.
Education & Skills Requirements
Bachelor’s Degree (BA/BS) with a concentration in Sciences or Logistics, with a minimum of twelve (12) years of experience including quality oversight roles such as technical elements or technical operations roles.
Minimum of 2 years of direct experience with supply chain strategy or technical elements (e.g. change controls, investigations, process documentation such as protocols, CPV, etc.), preferably with small molecule products.
Demonstrated skills for external-facing communications in written and verbal form.
Demonstrated success leading multi-functional teams driving continuous improvement and execution of strategic actions across a network (i.e. multiple groups/sites/functions). Travel is approximately 10%.
Entrepreneurship/Innovation – Meeting patient, customer, and organization’s needs by confronting difficult issues, offering creative alternatives, and taking action.
Decision Making/Influence – Identifying and understanding problems; gathering, analyzing, and interpreting information, establishing decision criteria, and identifying alternatives. Makes timely decisions using effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes.
Growth/Development/Change – Using new knowledge and skills on the job and learning through application. Modifying behavior based on self-awareness to improve impact and adaptability for major changes in work or environment (e.g., people, processes, structure or culture), trying new approaches.
Networking/Inclusion – Building partnerships; developing and leveraging relationships within and across work groups to achieve results. Working effectively across cultures, interpersonal styles, perspectives, motivations or backgrounds.
Execution Excellence/Ownership/Inspiration – Being proactive and setting high standards of performance for self and others; completing assignments or tasks; communicating effectively, clearly, and concisely to help stakeholders understand and retain the message; listening actively.
Required Skills
Active Pharmaceutical Ingredients (API)
Collaboration
Drug Product Manufacturing
Packaging
Pharmaceutical Drugs
Pharmaceutical Products
Product Quality
Product Quality Assurance
Quality Oversight
Small Molecule Drug Development
Small Molecule Drugs
Small Molecules
US and Puerto Rico Residents Only
Current employees apply to the role through the internal portal. Current contingent workers apply through the external portal.
We are committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please let us know if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the EEOC Know Your Rights and EEOC GINA Supplement. Learn more about your rights, including under California, Colorado and other U.S. State Acts.
U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions in the U.S. will be working a hybrid model consisting of three total days on-site per week, Monday through Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day unless business-critical tasks require an on-site presence. This model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work is performed at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. This guidance also does not apply to roles designated as “remote.”
Salary range for this role: $173,200.00 – $272,600.00. The successful candidate will be eligible for an annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, other insurance benefits for employee and family, retirement benefits, 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
Apply for this role through https://jobs.merck.com/us/en/ or via the Workday Jobs Hub if you are a current employee. The application deadline for this position is stated on this posting.
San Francisco Residents Only – We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
Los Angeles Residents Only – We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Search firm representatives: Merck & Co., Inc. does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms without a valid written agreement will be deemed the sole property of our company. No fee will be paid if a candidate is hired as a result of an agency referral without a pre-existing agreement.
Requisition ID: R390605
#J-18808-Ljbffr