Senior Manager, Qa Disposition Daily Ops

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The Senior Manager, Quality Disposition Daily Operations is responsible for leading the drug product and raw material 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 act as a Subject Matter Expert for the site. Work scope will include release for commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in S-12.
Shift Available:

• Sunday - Wednesday day shift.

Responsibilities:

• Assures timely review of manufacturing batch records and QC testing prior to disposition. Critically reviews change controls, deviations, complaints, investigations, environmental monitoring results and CAPAs associated to drug product prior to release.
• Assure 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.
• Compiles and coordinates Quality Operations Batch Disposition metrics as needed.
• 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.
• Responsible for oversight and implementation of the Drug Product disposition program
• Hire, train, and coach disposition personnel to execute the book of work and sustain Drug Product disposition programs.
• 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.
• Oversee and approve all procedural documentation for the drug product disposition program.
• Manage lot disposition activities and communicate lot disposition status including communication to the clinical teams; participate in Material Review Board meetings as needed and evaluate recommendations made by the board during product disposition.
• 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.
• Assures timely review of documentation for manufacturing operations batch records and QC testing.
• Assures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs while managing archival batch release GMP documentation for the site.
• Performs supplemental tasks as required by leadership.

Knowledge & Skills:

• Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance.
• Demonstrated ability to work in an organization with a range of technically, culturally, and geographically diverse teams, to influence areas not under direct control to achieve disposition objectives.
• Demonstrated strong leadership capability with the ability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results that meet high-quality requirements with tight deadlines.
• Can effectively communicate simple and complex issues in written format or in person through face-to-face or virtual environments.
• Effectively communicates internally within the function and with internal and external cross-functional teams.
• Manages conflict and issues with internal and external customers. Demonstrates negotiation skills in internal and external cross-functional teams.
• Ability to make independent and objective decisions and to work with minimal supervision.
• Must possess an independent mindset.
• Requires minimal direction to complete complex tasks; completes routine tasks with little or no supervision. Able to effectively multi-task.
• Work is self-directed.
• Confident in making decisions for non-routine issues.
• Proposes solutions for complex issues and works with management to resolve.
• Follows established procedures and performs work as assigned.
• Advanced ability to interpret results and situations and articulate recommendations for resolution.
• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, environmental monitoring programs and CAPA management.
• Manages quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Must possess an independent mindset and tenacity.
• Routinely recognizes Quality issues and solves problems.
• Is recognized Subject Matter Expert within the site.
• Provides guidance to other employees in interpretation of complex data.
• Contributes to goals within the work group.
• Excellent verbal and written communication skills.

Basic Requirements:

• Bachelor's degree in a biological science, engineering, microbiology or similar.
• 8 years of experience within cGMP industry.
• 3-5 years of experience within Quality Assurance.
• Strong people leadership experience a must.

Preferred Requirements:

• Advanced degree preferred.
• Disposition experience.

Working Conditions:

• Work is performed in a typical office environment with standard office equipment available and used.
• Work is generally performed seated but may require standing and walking up to 10% of the time.
• Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

BMSCART, #LI-Onsite
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
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On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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