Senior Manager, Quality Assurance (QA)

Position SummaryThe Senior Manager, Quality Assurance is responsible for leading the Quality Assurance function to ensure full compliance with 21 CFR Parts 210/211 and applicable regulatory expectations governing pharmaceutical manufacturing. This role provides strategic and operational oversight of the Quality Management System (QMS), batch disposition, and quality oversight of manufacturing operations.This individual will serve as a key quality leader for the site, ensuring that systems, processes, and personnel consistently deliver products that meet identity, strength, quality, and purity requirements. The role is accountable for maintaining inspection readiness, driving continuous improvement, and supporting business growth in a compliant manner.Key Responsibilities· Quality Management System (QMS) Leadership· Own and oversee the site Quality Management System, including:o Deviations / Investigationso CAPAo Change Controlo Document Controlo Training Systems· Ensure systems are compliant, efficient, and scalable for growth· Lead continuous improvement initiatives to enhance quality system effectiveness· Batch Disposition & Product ReleaseProvide final QA review and approval of:· Batch records· Analytical data· Certificates of Analysis (COA) / Certificate of Irradiation (COI)· Make disposition decisions ensuring product meets all specifications and regulatory requirements· Ensure timely product release to support operational and commercial needsManufacturing Quality OversightProvide QA oversight of:· Aseptic and/or sterile manufacturing operations· Non-sterile production activities· Cleaning and contamination control practices· Ensure adherence to approved procedures and cGMP requirements· Partner with Manufacturing to resolve issues in real-time while maintaining complianceRegulatory Compliance & Inspection Readiness· Serve as primary QA lead outside of the room during regulatory inspections (e.g., FDA)· Ensure continuous state of inspection readiness across the site· Support responses to regulatory observations (e.g., 483s, Untitled Letters)· Interpret and apply regulatory requirements to site operationsDeviation, Investigation & CAPA Oversight· Ensure robust, timely, and scientifically sound investigations· Drive root cause analysis using structured methodologies (e.g., 5-Why, 6M, FMEA)· Approve CAPAs and verify effectiveness· Identify systemic issues and implement preventative controlsSupplier & Material Quality· Oversee supplier qualification and material release processes· Ensure incoming materials meet quality requirements prior to use· Support audits and quality agreements with suppliers and contract partnersDocumentation & Data IntegrityEnsure all GMP documentation is:· Accurate· Complete· Contemporaneous· Compliant with ALCOA+ principles· Oversee implementation and maintenance of electronic systems (e.g., eQMS)· Ensure strong data governance and audit trail integrityLeadership & People Development· Lead, mentor, and develop QA staff· Establish clear performance expectations and accountability· Build a quality culture focused on compliance, ownership, and continuous improvement· Ensure personnel are adequately trained and qualified for GMP activitiesCross-Functional Collaboration· Partner with QC, Manufacturing, Regulatory, and Operations· Support new product introduction (NPI), tech transfer, and process improvements· Provide quality guidance during change implementation and scale-upMetrics & Continuous ImprovementEstablish and monitor QA KPIs such as:· Deviation closure timelines· Right-first-time batch records· CAPA effectiveness· Drive operational excellence using Lean principles where appropriateQualificationsEducation· Bachelor’s or Master’s degree in Life Sciences, Chemistry, Pharmacy, or related field· Experience· 5+ years of experience in pharmaceutical Quality Assurance· 3–5+ years in leadership roles with direct people management· Experience in sterile, aseptic, or parenteral manufacturing strongly preferredTechnical ExpertiseStrong working knowledge of:· 21 CFR Parts 210/211· cGMP requirements and FDA expectations· Quality systems and batch release processesDemonstrated experience with:· Deviations, CAPA, and investigations· Regulatory inspections and responses· Risk management tools (FMEA, risk assessments)Systems & Tools· Experience with electronic Quality Management Systems (eQMS) such as MasterControl preferred· Familiarity with ERP and laboratory systems (LIMS) is a plusPreferred Qualifications· Experience in a 503B outsourcing facility, CDMO, or small-to-mid size GMP organization· Proven success in supporting or leading regulatory remediation efforts· Experience scaling quality systems in a growing organization· Professional certifications (e.g., ASQ CQE, Six Sigma) preferredKey Competencies· Strong leadership and decision-making ability· Deep understanding of GMP compliance and regulatory expectations· Excellent problem-solving and root cause analysis skills· Ability to balance compliance with operational efficiency· Effective communication across all levels of the organizationBenefits:401(k)401(k) matchingDental insuranceEmployee assistance programEmployee discountFlexible spending accountHealth insuranceLife insurancePaid time offVision insuranceApplication Question(s):Do you have a Bachelor’s or Master’s degree in Life Sciences, Chemistry, Pharmacy, or related field Experience? RequiredDo you have 3–5+ years in leadership roles with direct people management? RequiredDo you have at elaast 4 years of experience in sterile, aseptic, or parenteral manufacturing? Strongly preferred.Do you have strong working knowledge of 21 CFR Parts 210/211? RequiredDo you have strong working knowledge of Quality systems and batch release processes cGMP requirements and FDA expectations? RequiredDo you have demonstrated experience with Deviations, CAPA, and investigations? RequiredDo you have demonstrated experience with regulatory inspections and responses? RequiredDo you have demonstrated experience with Risk management tools (FMEA, risk assessments)? RequiredEducation:Master's (Preferred)Experience:pharmaceutical Quality Assurance: 6 years (Required)MasterControl e-QMS: 3 years (Preferred)Work Location: In person