Senior Manager, Quality Control Labs
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Job Location:
Somerset County, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
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 AbbVie.
Qualifications :
- Minimum bachelors degree required preferably in Physical or Life Sciences Pharmacy or Engineering; masters 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).
Additional Information :
AbbVie 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.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Laboratory Experience
- Quality Assurance
- Construction Experience
- FDA Regulations
- ISO 9001
- Assays
- Quality Systems
- Quality Control
- Quality Management
- cGMP
- QA/QC
- HACCP
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
