Leads the Branchburg Quality Control Laboratories and serves as integral member of the Quality leadership team. The role is accountable for ensuring compliance with all applicable regulatory and compliance requirements and must ensure the site is anticipating and building capabilities in-line with regulatory expectations and trends. Provides strategic, scientific, and operational leadership for all QC testing activities supporting the commercial manufacturing of tissue products. This role oversees laboratory functions, personnel and budget management, method validation and transfer, regulatory compliance, and continuous improvement initiatives. The Senior Manager will partner cross-functionally to maintain reliable product quality and throughput.

Responsibilities:

• Lead a team of Quality compliance professionals to manage daily operations of the QC labs (microbiology, mechanical,sterility, etc.), including personnel supervision, scheduling, and workload prioritization.

• Refine, update, and monitor the inspection readiness system that includes prior inspection/audit findings and build linkages to corporate or enterprise-level quality teams. Ensure compliance with GMP, GLP, FDA, EMA, and other applicable regulatory standards.

• Oversee validation, execution, and troubleshooting of microbiological and sterility assurance methods (bioburden, endotoxin, sterility testing, environmental monitoring, etc.) for both internal processes as well as any that are externalized to CROs.

• Build, deploy and monitor other operational, quality/compliance programs and learning and performance elements to advance the one operations and quality culture mindset maturity within the site operations sites and functions. Perform proactive compliance assessments and evaluations of relevant facility or system changes, new product implementations, risk management activities, investigations/complaints, quality plans.

• Mentor and develop quality and compliance staff within the region as part of organizational development (in partnership with site quality leaders).

• Deploy and implement relevant information / actions to the site from various regulatory, compliance, quality management, CoE, and operational or quality improvement initiatives / forums within Abb Vie.

• Minimum bachelor’s degree required preferably in Physical or Life Sciences, Pharmacy, or Engineering; master’s degree or PhD preferred. Certified Quality Engineer or formal training in quality engineering or statistics is preferred.

• 8+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical, biologics, device or chemical or other related industry.

• 4+ years of supervisory/technical leadership experience.

• Must have a basic understanding and working knowledge of the physical and chemical characteristics of the products, including raw materials, manufactured at the plant.

• Must be familiar with use of statistical quality systems, electronic document management and laboratory information management.

• Must also be familiar with Quality policies as well as cGMP and other regulatory requirements.

• Must have effective people management and communication skills necessary to supervise those reporting directly or through subordinates as well as establish and maintain effective working relationships among other key individuals in manufacturing, materials management, engineering, product development, Quality Systems, Product QA, Quality Control, Information Systems and Regulatory Affairs and must demonstrate sound judgment in evaluating and acting on day-to-day situations.

• Strong communication Skills, both oral and written

Preferred qualifications

• Extensive skills in microbiology and sterility.
• Demonstrated experience in medical device regulations and clean room specifications (e.g. FDA 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 820, ISO 13485, ISO 14971, ISO 15189, IVDR, CAP, and CLIA).

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

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About Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.