Senior Manager, CTO Network QA Disposition

Celgene • Summit, NJ

81d • $143,180 - $173,504 • Hybrid

About The Position

The 2nd Shift Senior Manager, QA Disposition Daily Operations is responsible for leading the drug product disposition activities at the S-12 Summit West facility. Responsibilities include overseeing final release of drug product, review, and approval of site-specific procedures and GMP documentation in accordance with BMS policies, standards, procedures and global cGMPs. This individual will lead a team responsible for ensuring timely and accurate delivery of disposition requirements, maintenance and review of disposition associated SOPs, support of APQR generation and function as a Subject Matter Expert in disposition for the site. Work scope will include release for commercial manufacturing and clinical manufacturing for all cell therapy products manufactured at the Summit West, S-12 facility.

Requirements

• A Bachelor's degree in a biological science, engineering, microbiology or similar.
• Strong Disposition experience required.
• A minimum 8-years relevant work experience within a cGMP environment.
• A minimum 3-years of people leadership experience in the pharmaceutical or related industry.

Responsibilities

• Responsible for the oversight and implementation of the Drug Product disposition program at the site.
• Oversee the generation of all disposition certification as applicable; Certificate of Analysis (CoA), Dose, RFI (release for infusion) certificate, etc.
• Drives and oversees the timely and efficient assessment of all disposition inputs i.e. manufacturing batch records, QC testing, change controls, deviations, complaints, investigations, environmental monitoring results and CAPAs associated to drug product prior to release.
• Oversees and approves all standard operating procedures (SOPs) and procedural documentation related to the drug product Disposition program at the site.
• Updates and procures approval of job descriptions for department personnel.
• Performs and oversees the training of personnel.
• Effectively hires, develops, counsels, manages, and motivates staff.
• Writes and administers performance appraisals for department personnel.
• Hire, train, and coach disposition personnel to execute the book of work and sustain Drug Product disposition programs.
• Assures product quality and compliance by enforcing quality assurance policies and procedures; ensures the required processes, procedures, systems, and resources are in place to enable a compliant disposition of cell therapy products.
• Responsible for communicating and updating lot disposition status including communication at site and network levels.
• Oversees compilation of and presents disposition metrics to senior management.
• Supports site and functional teams during regulatory inspections or audits, which may include direct interaction with inspectors/auditors as well as writing and/or reviewing responses.
• Represent the S-12 facility in network initiatives for harmonization and at community of practices.
• Approve change controls related to disposition and associated activities including Quality Control specifications.
• Performs projects as required by senior management.

Benefits

• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Other perks like tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Merchant Wholesalers, Nondurable Goods
• Education Level: Bachelor's degree