Senior Manager, Quality Assurance (QA)
Veranova L P
Summary
The Sr Manager, QA is responsible for leading the Veranova Quality Assurance team, managing quality oversight of the manufacturing process and associated operations. This includes leading and managing multiple QA teams for batch record review, batch disposition, and on the floor QA support to ensure GMP compliance across all stages of manufacturing, as well as disposition and release of starting materials and customer facing Quality program leads for each client. The person filling this role will be responsible for the leadership, development and training of team members within their oversight as well as providing supportive leadership and strategic direction to operate with and maintain compliance to regulatory and industry quality standards. The role is expected to build strong collaborative relationships with internal and external stakeholders to drive compliance and continuous improvement of GMP operations. The position is 100% on site 1st shift at our Devens, MA facility.
Job description
Core Responsibilities
- Evaluate and implement systems, methods, techniques, and solutions to complex quality compliance issues.
- Interface with Clients for project planning, and problem resolution with a strong customer service approach.
- Lead or support implementation of critical compliance systems and provide recommendations to operations management.
- Recommends the stop of any manufacture and/or distribution of a product if necessary.
- Manages the review, approval, and ensures delivery of Quality Assurance related training content and programs including new Quality Assurance initiatives for continuous improvement.
- Analyzes trends associated with data, proficiency testing, equipment/supply/reagent defects and supports development of solutions as appropriate.
- Direct and advise the Quality Assurance group to achieve long and short-term goals and objectives.
- Develops, improves, and revises Standard Operating Procedures (SOPs) and Quality Policies as required/needed.
- Ensures the review and approval of equipment qualification protocols and results.
- Participates in internal auditing programs to assure compliance with regulatory requirements and company standards.
- Partner collaboratively with Production, Maintenance, and QC for all Quality decisions within the scope of the role.
Qualifications
- BS or MS in Chemistry, Engineering or related field required.
- Must have a minimum of 10 years of experience in Quality Assurance in an FDA regulated industry.
- Experience in an API in GMP environment is preferred.
- Minimum of 7 years of supervisory experience required; Proven ability to lead and coach, and motivate employees, clearly communicate job requirements, and effectively manage performance of staff.
- Must have established experience in Analytical and Quality Control support of Active Pharmaceutical Ingredient (API).
- Knowledge and previous experience with GMP, ICH Q7, and 21 CFR Part 11; Expertise in FDA regulations, GMPs, and Quality Systems relevant to pharmaceutical manufacturing.
- Experience with hosting and/or regulatory facing inspection responsibilities is required.
- Knowledge of Inventory Management, LIMS, Quality Management software systems experience desired.
- Must be a change agent and have strong interest in succession planning and professional development of their team(s); Ability to change priorities in response to company demands while continuing to deliver exceptional work quality through leadership by example.
Requirements
- BS or MS in Chemistry, Engineering or related field required.
- Minimum of 10 years of experience in Quality Assurance in an FDA regulated industry.
- Experience in an API in GMP environment is preferred.
- Minimum of 7 years of supervisory experience required.
- Proven ability to lead and coach, and motivate employees, clearly communicate job requirements, and effectively manage performance of staff.
- Established experience in Analytical and Quality Control support of Active Pharmaceutical Ingredient (API).
- Knowledge and previous experience with GMP, ICH Q7, and 21 CFR Part 11.
- Expertise in FDA regulations, GMPs, and Quality Systems relevant to pharmaceutical manufacturing.
- Experience with hosting and/or regulatory facing inspection responsibilities is required.
- Knowledge of Inventory Management, LIMS, Quality Management software systems experience desired.
- Must be a change agent and have strong interest in succession planning and professional development of their team(s).
- Ability to change priorities in response to company demands while continuing to deliver exceptional work quality through leadership by example.
Benefits
- Health & wellness benefits
- Mental health resources
- Wellness programs
- Generous PTO
- Holiday pay
- Performance-based bonuses
- 401(k) plan with company match
- LinkedIn Learning
- Workshops
- Conferences
- Mentorship
- Tuition assistance
Company overview
Veranova L.P. is a global leader in contract development and manufacturing organization (CDMO) services, specializing in the development and production of complex active pharmaceutical ingredients (APIs) for pharmaceutical and biotechnology companies. With over 50 years of industry experience, Veranova focuses on specialist niches requiring expertise in highly regulated and complex chemistries, including controlled substances, highly potent APIs, and specialty modalities such as antibody-drug conjugates (ADCs), PROTACs, and oligonucleotides. The company operates a global network of cGMP-compliant facilities in the United States and United Kingdom, offering comprehensive services spanning solid form sciences, process development, analytical method development, and commercial-scale manufacturing. Veranova has contributed to approximately 15% of FDA-approved small molecule drugs since 2014 and maintains over 200 active Drug Master Files, demonstrating its significant impact on the pharmaceutical industry. The company's mission centers on enabling current and next-generation therapeutics to improve patient lives through innovative manufacturing solutions and collaborative partnerships.