Manager, Manufacturing Quality Assurance

About the role

The Manager, Manufacturing Quality Assurance (MQA) is responsible for directing and overseeing all MQA activities to ensure consistent quality support of daily manufacturing operations and product lot release. This role serves as the primary Quality liaison for internal departments, providing guidance on product, process, and material issues while ensuring adherence to regulatory, corporate, and customer quality standards.

Responsibilities

• Provide daily Quality Assurance oversight and leadership to support commercial manufacturing operations, including in-process inspections, final product inspections, and on-the-floor batch record reviews.
• Serve as the primary Quality contact for internal departments regarding product, process, and material issues.
• Ensure timely resolution of quality issues to support uninterrupted manufacturing and compliant lot release.
• Maintain 24/7 availability to support urgent manufacturing or quality-related inquiries.
• Oversee and support Quality elements of validation activities, including report closures and adherence to protocol requirements.
• Review and approve quality documentation including investigations, change controls, and deviations.
• Hire, train, supervise, and develop the Manufacturing Quality Assurance (MQA) team, conducting regular performance evaluations to maintain a high-performing team.
• Provide cGMP training and mentoring to Quality and Production personnel to reinforce compliance and quality culture.
• Lead and support site-level and cross-functional strategic quality initiatives and global projects involving product changes, process improvements, or service enhancements.
• Drive continuous improvement efforts focused on quality, compliance, and operational efficiency in alignment with current regulatory expectations and industry best practices.
• Collaborate with other functional leaders to maintain alignment between quality and production goals.
• Act as the resident QA expert for manufacturing operations, providing technical guidance on compliance, product release, inspection readiness, and issue resolution.
• Ensure that all manufactured products meet regulatory, customer, and internal requirements for quality, safety, and efficacy.

Requirements

• BS or BA in Science, Chemistry or Biology.
• Minimum of five (5) years quality assurance, regulatory compliance management or related work experience.
• Minimum of two (2) years in a team leadership role of professional level individual contributors.
• Minimum of five (5) years in an aseptic/sterile product facility.
• Demonstrated understanding of laboratory, manufacturing, packaging, regulatory, compliance, and quality assurance requirements for biological and drug product manufacturing.
• Minimum of 10 years of progressively greater responsibilities in the pharmaceutical products/medical services industry, including QA, Regulatory, Operations, Project, Technical, and Laboratory experience, preferred.
• Experience working with third-party contract manufacturing in the Pharmaceutical industry, strongly preferred.

Qualifications

• Leadership in audits and serving as a QA subject matter expert.
• Proven ability to work independently and lead teams with strategic and innovative thinking.

Skills

• Strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions.

Benefits

Generous benefit options (eligible first day of employment)

Paid training, vacation and holidays (vacation accrual begins on first day of employment)

Career advancement opportunities

Education reimbursement

401K program with matching contributions

Learning platform

And more!

Pay

TBD

Schedule

24/7 on-call basis