Associate Director, GMP Operational Quality (QA Ops for QC)
Scorpion Therapeutics, Boston, Massachusetts, us, 02298
Role Summary
The Associate Director, GMP Operational Quality is responsible for quality oversight of QC data review for both non-routine and routine cGMP process testing and stability testing of Cell & Genetic Therapy products. The role leads team activities and personnel development to ensure high-quality deliverables and compliance with regulatory requirements. This is an on-site role with five days per week on-site and ad hoc flexibility, requiring collaboration with cross-functional partners and mentoring of staff to support project teams. Responsibilities
Lead a Quality team: primarily responsible for providing quality oversight and support to business activities within purview at Vertex Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions Oversee CMO/Vendor performance, establishment of Quality Agreements and adherence of Quality Agreement terms Enable team to achieve team goals/objectives and enable their individual career development Develop and maintain compliant quality processes to support GMP activities Oversee the QA support of Change Controls, GMP investigations and associated CAPAs. Track performance metrics and report to Sr Management; develops tactics to improve performance outcomes Participate in inspection readiness activities and lead Quality development discussions as necessary during regulatory site inspections. Support review of regulatory submissions, as applicable Lead continuous improvements of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources. Lead and follow up on any QLT action items assigned. Identify and communicate risks and assist with risk mitigation plans as necessary Supports internal audit or external audit programs; assists in preparation of audit responses Provide comprehensive knowledge support for partner and regulatory agency audits Assist management team in budgeting and scheduling Responsible for the following activities related to people management responsibilities: Talent Acquisition/ Recruiting/Interviewing/ Selection/Onboarding Performance Management (goals, monitoring, reviews); Monitoring /Supporting Employee Engagement and Retention; Succession Planning; Accomplishing staff results by communicating job expectations, planning, coaching, training and developing personal growth opportunities through IDPs. Accountable to provide oversight of day to day team operations Assists with workforce planning/resource modeling and to update through forecasting activities Qualifications
Required: Seven (7)+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in a cGMP related industry, with four (4) or more years of work experience in proven leadership/supervision and experience within a sterile manufacturing site and sterilization activities. Required: Must have experience in ethylene oxide, steam sterilization, and gamma radiation requirements. Preferred: Knowledge of contamination control practices and engineering controls for cleanroom operations and critical systems (i.e., process air, water for injection, etc.). Preferred: Knowledge of standard microbiological procedures (sterility testing, environmental monitoring, bioburden, and bacterial endotoxin testing). Skills
In-depth and specialized knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and managing quality in support GMP manufacturing Demonstrated success in building high-performing teams and skilled at managing team and individual development Strong management skills with the ability to lead and motivate a team in a fast-paced environment while maintaining a high degree of quality, accuracy and timeliness Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers; skilled at applying project management processes / tools to lead meetings, assist with project planning, and facilitate attainment of project objectives Ability to independently lead cross-functional teams and represent the interests, strategies and objectives of Quality unit Strong skills in mentoring staff and transferring technical knowledge to enable their capabilities and development Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders, customers, or vendors to adopt of a new point of view and/or to take action Demonstrated ability to evaluate complex quality matters and make decisions utilizing risk-based approach; identifies and leverages the appropriate expertise to implement solutions Substantial experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA Extensive exposure with multiple regulatory agencies across applicable GxPs during inspections Substantial experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva) Education
Preferred Master's degree or relevant comparable background.
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The Associate Director, GMP Operational Quality is responsible for quality oversight of QC data review for both non-routine and routine cGMP process testing and stability testing of Cell & Genetic Therapy products. The role leads team activities and personnel development to ensure high-quality deliverables and compliance with regulatory requirements. This is an on-site role with five days per week on-site and ad hoc flexibility, requiring collaboration with cross-functional partners and mentoring of staff to support project teams. Responsibilities
Lead a Quality team: primarily responsible for providing quality oversight and support to business activities within purview at Vertex Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions Oversee CMO/Vendor performance, establishment of Quality Agreements and adherence of Quality Agreement terms Enable team to achieve team goals/objectives and enable their individual career development Develop and maintain compliant quality processes to support GMP activities Oversee the QA support of Change Controls, GMP investigations and associated CAPAs. Track performance metrics and report to Sr Management; develops tactics to improve performance outcomes Participate in inspection readiness activities and lead Quality development discussions as necessary during regulatory site inspections. Support review of regulatory submissions, as applicable Lead continuous improvements of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources. Lead and follow up on any QLT action items assigned. Identify and communicate risks and assist with risk mitigation plans as necessary Supports internal audit or external audit programs; assists in preparation of audit responses Provide comprehensive knowledge support for partner and regulatory agency audits Assist management team in budgeting and scheduling Responsible for the following activities related to people management responsibilities: Talent Acquisition/ Recruiting/Interviewing/ Selection/Onboarding Performance Management (goals, monitoring, reviews); Monitoring /Supporting Employee Engagement and Retention; Succession Planning; Accomplishing staff results by communicating job expectations, planning, coaching, training and developing personal growth opportunities through IDPs. Accountable to provide oversight of day to day team operations Assists with workforce planning/resource modeling and to update through forecasting activities Qualifications
Required: Seven (7)+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in a cGMP related industry, with four (4) or more years of work experience in proven leadership/supervision and experience within a sterile manufacturing site and sterilization activities. Required: Must have experience in ethylene oxide, steam sterilization, and gamma radiation requirements. Preferred: Knowledge of contamination control practices and engineering controls for cleanroom operations and critical systems (i.e., process air, water for injection, etc.). Preferred: Knowledge of standard microbiological procedures (sterility testing, environmental monitoring, bioburden, and bacterial endotoxin testing). Skills
In-depth and specialized knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and managing quality in support GMP manufacturing Demonstrated success in building high-performing teams and skilled at managing team and individual development Strong management skills with the ability to lead and motivate a team in a fast-paced environment while maintaining a high degree of quality, accuracy and timeliness Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers; skilled at applying project management processes / tools to lead meetings, assist with project planning, and facilitate attainment of project objectives Ability to independently lead cross-functional teams and represent the interests, strategies and objectives of Quality unit Strong skills in mentoring staff and transferring technical knowledge to enable their capabilities and development Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders, customers, or vendors to adopt of a new point of view and/or to take action Demonstrated ability to evaluate complex quality matters and make decisions utilizing risk-based approach; identifies and leverages the appropriate expertise to implement solutions Substantial experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA Extensive exposure with multiple regulatory agencies across applicable GxPs during inspections Substantial experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva) Education
Preferred Master's degree or relevant comparable background.
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