Senior Manager, Quality Assurance (QA)

Senior Manager, Quality Assurance (QA) at Wells Pharmacy Network Senior Manager, Quality Assurance (QA) at Wells Pharmacy Network in Dyersburg, Tennessee Posted in about 23 hours ago.

Type:

full-time

Job Description:

Position Summary The 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 / Investigations o CAPA o Change Control o Document Control o Training Systems
• Ensure systems are compliant, efficient, and scalable for growth
• Lead continuous improvement initiatives to enhance quality system effectiveness
• Batch Disposition & Product Release Provide 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 needs Manufacturing Quality Oversight Provide 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 compliance Regulatory 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 operations Deviation, 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 controls Supplier & 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 partners Documentation & Data Integrity Ensure 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 integrity Leadership & 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 activities Cross-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-up Metrics & Continuous Improvement Establish and monitor QA KPIs such as:
• Deviation closure timelines
• Right-first-time batch records
• CAPA effectiveness
• Drive operational excellence using Lean principles where appropriate Qualifications Education
• 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 preferred Technical Expertise Strong working knowledge of:
• 21 CFR Parts 210/211
• cGMP requirements and FDA expectations
• Quality systems and batch release processes Demonstrated 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 plus Preferred 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) preferred Key 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 organization

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Employee discount Flexible spending account Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person