Senior Manager For Quality
We are in search of a forward-thinking Senior Manager for Quality to lead all aspects of the Quality Operations and Quality Systems at our facility. This is a pivotal leadership role for someone passionate about quality, team development, and innovation in advanced therapies. You'll provide operational quality oversight and ensure compliance and inspection readiness in-line with global regulatory standardswhile shaping the future of our Quality organization.
Key Responsibilities :
- Guide and empower a team of professionals specializing in Quality Operations and Systems, assisting with GMP manufacturing and warehouse operations
- Ensure inspection readiness and regulatory compliance across all site quality systems
- Lead all aspects of Supply Chain Quality, including supplier management, change notifications, and corrective actions
- Develop a culture of quality by directing teams through policies, procedures, and guidelines
- Establish culture of real-time quality oversight for manufacturing floor events and documentation review
- Track and report key performance indicators to assess quality system effectiveness
- Represent the site during regulatory inspections, corporate audits, and client visits
- Drive risk management initiatives, including risk register updates and mitigation strategies
- Collaborate cross-functionally on continuous improvement projects to elevate site performance and customer satisfaction
- Serve as a strategic partner to clients, addressing quality-related inquiries and aligning product control strategies
Qualifications :
Bachelor's degree in a scientific or technical field required10+ years in Quality Assurance or leadership roles within biologics, pharmaceuticals, or cell / gene therapyStrong knowledge of 21 CFR, ICH Q9 / Q10, ISO-14644, GAMP5, ASTM-E2500, and EU regulationsProven success managing regulatory inspections (FDA, EMA, Health Canada)Hands-on experience with audits, deviation investigations, and GMP batch record reviewDemonstrated ability to build and lead hard-working teamsKnowledge, Skills, Abilities :
Deep understanding of GMP regulations and global quality standardsStrategic problem solver with a practical approach to complex quality challengesExcellent communication and presentation skillsStrong organizational and prioritization capabilitiesSkilled in technical writing and analytical problem-solvingCollaborative leadership style with a focus on continuous improvementPhysical Requirements :
Ability to gown for cleanroom environmentsCapacity to read and review documentation for extended periodsMust be able to talk, hear, sit, and stand for long durationsOccasionally required to lift, walk, reach, stoop, kneel, or crouchWhat We Offer :
Competitive compensation and annual performance bonusMerit-based annual salary increasesMedical, dental, and vision benefits starting Day 1Generous paid time off and designated holidays401(k) with company matchTuition reimbursementEmployee referral bonusCareer development and advancement opportunitiesOther :
Relocation assistance is not providedMust be legally authorized to work in the United States now and in the future, without sponsorshipMust be able to pass a comprehensive background check, which includes a drug screening