Senior Quality Systems Specialist
Kindeva Drug Delivery, Simi Valley, CA, United States
The Impact You Will Make
The Senior Quality Systems Specialist serves as a site-level authority for quality systems analytics and performance governance support. This role develops and leads data-driven methodologies that shape the organization’s quality strategy and directly influence operational and regulatory decision-making. The specialist exercises independent judgment in evaluating quality risks, interpreting data, determining systemic improvements, and advising cross-functional leadership on matters of quality system metric performance and proactive quality planning. Work is performed with minimal supervision and requires substantial discretion on matters of significance to the organization’s compliance posture and product quality.
Responsibilities
Lead the continuous improvement of site-wide Quality System performance indicators, dashboards, and analytical models used by senior leadership to make regulatory and operational decisions.
Independently determine which metrics, statistical methods, and analytical tools provide the most accurate insight into compliance, quality trends, and system maturity.
Provide expert interpretation of quality-system performance data, identifying emerging risks and recommending corrective or preventive actions.
Serve as the primary owner of the Product Quality Review (PQR) program, including defining data requirements, evaluating quality signals, and drawing conclusions on product performance and systemic risks.
Chair PQR meetings, present risk-based conclusions, and drive cross-functional decision-making regarding quality improvements, complaint trends, and product lifecycle considerations.
Lead the Quality Metrics Review process by determining meaningful trends, assigning ownership for actions, and influencing decisions that impact compliance and manufacturing performance.
Apply advanced statistical methods (e.g., regression, capability studies, control charts) to evaluate quality attributes and process parameters, exercising judgment in selecting appropriate models and interpreting results for business impact.
Develop and validate analytical models that forecast potential compliance issues or manufacturing deviations, supporting leadership in strategic planning and risk mitigation.
Lead the development and governance of data-query structures, reporting standards, and analytical integrity within QMS and laboratory data environments; set standards for data accuracy and reporting consistency.
Provide specialized guidance to cross-functional teams on interpretation of quality data and compliance risk; lead or co-lead continuous improvement initiatives prioritized by risk and business impact.
Support regulatory and customer audits as a subject-matter expert for quality metrics, PQR processes, and analytics methodologies.
Required Skills and Experience
Bachelor’s degree in engineering, mathematics, or computer science; Master’s preferred. Equivalent experience may be substituted for formal education.
5+ years of manufacturing experience in the pharmaceutical industry with a Bachelor’s degree, or 3+ years with a Master’s degree.
Demonstrated ability to assess problems, identify solutions, and plan and implement necessary changes.
Experience working within quality systems (internal and/or external) preferred.
Familiarity with electronic Quality Management Systems (eQMS), such as MasterControl or Veeva, preferred.
Ability to work effectively both independently and in a team‑oriented environment.
Strong organizational skills with the ability to multitask and meet timelines.
Well‑developed communication and technical writing skills.
Qualified to work with controlled substances.
Preferred Experience
Master’s degree in engineering, mathematics, computer science, or a related technical field.
8+ years of experience in pharmaceutical or regulated‑industry manufacturing environments.
Hands‑on experience with electronic Quality Management Systems (eQMS) such as MasterControl or Veeva.
Demonstrated experience supporting regulatory inspections, internal audits, or technical assessments.
Prior involvement in process improvement, deviation/root‑cause investigations, or change management.
Certification(s) such as Six Sigma, Lean, PMP, or ASQ (CQE, CQA) are a plus.
Experience working with controlled substance handling protocols or DEA‑regulated activities.
Ability to interpret complex technical data and communicate findings clearly to cross‑functional teams.
Benefits
Eligible for a range of benefits including Medical, Dental, Vision, Health Savings Accounts, Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and 401(k).
California Notice
California residents should review our Notice for California Employees and Applicants before applying.
Equal Opportunity Employer
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
#J-18808-Ljbffr
The Senior Quality Systems Specialist serves as a site-level authority for quality systems analytics and performance governance support. This role develops and leads data-driven methodologies that shape the organization’s quality strategy and directly influence operational and regulatory decision-making. The specialist exercises independent judgment in evaluating quality risks, interpreting data, determining systemic improvements, and advising cross-functional leadership on matters of quality system metric performance and proactive quality planning. Work is performed with minimal supervision and requires substantial discretion on matters of significance to the organization’s compliance posture and product quality.
Responsibilities
Lead the continuous improvement of site-wide Quality System performance indicators, dashboards, and analytical models used by senior leadership to make regulatory and operational decisions.
Independently determine which metrics, statistical methods, and analytical tools provide the most accurate insight into compliance, quality trends, and system maturity.
Provide expert interpretation of quality-system performance data, identifying emerging risks and recommending corrective or preventive actions.
Serve as the primary owner of the Product Quality Review (PQR) program, including defining data requirements, evaluating quality signals, and drawing conclusions on product performance and systemic risks.
Chair PQR meetings, present risk-based conclusions, and drive cross-functional decision-making regarding quality improvements, complaint trends, and product lifecycle considerations.
Lead the Quality Metrics Review process by determining meaningful trends, assigning ownership for actions, and influencing decisions that impact compliance and manufacturing performance.
Apply advanced statistical methods (e.g., regression, capability studies, control charts) to evaluate quality attributes and process parameters, exercising judgment in selecting appropriate models and interpreting results for business impact.
Develop and validate analytical models that forecast potential compliance issues or manufacturing deviations, supporting leadership in strategic planning and risk mitigation.
Lead the development and governance of data-query structures, reporting standards, and analytical integrity within QMS and laboratory data environments; set standards for data accuracy and reporting consistency.
Provide specialized guidance to cross-functional teams on interpretation of quality data and compliance risk; lead or co-lead continuous improvement initiatives prioritized by risk and business impact.
Support regulatory and customer audits as a subject-matter expert for quality metrics, PQR processes, and analytics methodologies.
Required Skills and Experience
Bachelor’s degree in engineering, mathematics, or computer science; Master’s preferred. Equivalent experience may be substituted for formal education.
5+ years of manufacturing experience in the pharmaceutical industry with a Bachelor’s degree, or 3+ years with a Master’s degree.
Demonstrated ability to assess problems, identify solutions, and plan and implement necessary changes.
Experience working within quality systems (internal and/or external) preferred.
Familiarity with electronic Quality Management Systems (eQMS), such as MasterControl or Veeva, preferred.
Ability to work effectively both independently and in a team‑oriented environment.
Strong organizational skills with the ability to multitask and meet timelines.
Well‑developed communication and technical writing skills.
Qualified to work with controlled substances.
Preferred Experience
Master’s degree in engineering, mathematics, computer science, or a related technical field.
8+ years of experience in pharmaceutical or regulated‑industry manufacturing environments.
Hands‑on experience with electronic Quality Management Systems (eQMS) such as MasterControl or Veeva.
Demonstrated experience supporting regulatory inspections, internal audits, or technical assessments.
Prior involvement in process improvement, deviation/root‑cause investigations, or change management.
Certification(s) such as Six Sigma, Lean, PMP, or ASQ (CQE, CQA) are a plus.
Experience working with controlled substance handling protocols or DEA‑regulated activities.
Ability to interpret complex technical data and communicate findings clearly to cross‑functional teams.
Benefits
Eligible for a range of benefits including Medical, Dental, Vision, Health Savings Accounts, Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and 401(k).
California Notice
California residents should review our Notice for California Employees and Applicants before applying.
Equal Opportunity Employer
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
#J-18808-Ljbffr