Senior Manager, Quality Assurance (QA)

Veranova; Northern (KY); Hybrid; USD 155,000 - 175,000; Full time

Benefits offered by this job

Health & Wellness

401(k) Plan with company match

Tuition Assistance

Job summary

Veranova seeks a Senior Manager, Quality Assurance (QA) to lead the QA team, oversee manufacturing quality oversight, batch review and release, and ensure GMP compliance across operations at the Devens, MA facility.

The role requires extensive QA leadership experience in an FDA-regulated environment, with strong knowledge of GMP, ICH Q7 and 21 CFR Part 11. Salary ranges reflect market data and internal equity.

Qualifications

• BS or MS in Chemistry, Engineering or related field required.
• Minimum of 7 years of supervisory experience; proven ability to lead and coach teams.
• Experience with GMP, ICH Q7, and 21 CFR Part 11; FDA regulatory knowledge and quality systems.

Responsibilities

• Lead QA teams for batch record review, disposition, and on-the-floor QA support to ensure GMP compliance.
• Develop, revise SOPs and Quality Policies as needed.
• Manage training content and programs for Quality Assurance staff.

Education

BS or MS in Chemistry, Engineering or related field

Tools

LIMS

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Senior Manager, Quality Assurance (QA)

Full Time - Salary Devens, MA, US

7 days ago Requisition ID: 1622

Senior Manager, Quality Assurance (QA)

At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference. Every role at Veranova plays a part in delivering an exceptional customer experience through ownership and integrity.

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.

Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients.

Role Overview:

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.

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.

• Additional assignments/ duties to support team objective and contribute to the Veranova mission may evolve based on business needs.

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.

Salary Range:

The salary range for this role is $155,000–$175,000. This range represents a good‑faith estimate of the compensation we expect to offer for this position at the time of posting. Actual compensation will be based on factors such as relevant experience, skills, qualifications, and internal equity. In exceptional cases, compensation may exceed the stated range.

All full-time employees are eligible to participate in our annual incentive bonus program. Bonus targets vary by career level and are based on individual and company performance.

Our Commitment:

• Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies.
• Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs.
• Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
• Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you don’t meet every qualification, we encourage you to apply. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team.

Additional Information:

Applicants for this role must be authorized to work in the United States without further employer sponsorship.

For applicants who may require a reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to [e-mail] in order to confirm your request for an accommodation. Please include the job number, title, and location of role. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Veranova employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

All your information will be kept confidential according to EEO guidelines.

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.

All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice .