Senior Manager, CTO Network QA Disposition

Role Summary

Senior Manager, CTO Network QA Disposition. Manages drug product disposition activities at the Summit West facility, including final release, SOP/document review, and APQR support for cell therapy products, across commercial and clinical manufacturing. Leads a team to ensure timely and accurate disposition deliverables, maintains disposition SOPs, and serves as a Subject Matter Expert in disposition for the site.

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.

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. Interacts well with internal and external cross-functional teams.
• Manages conflict and issues with internal and external customers. Demonstrates strong negotiation skills in internal and external cross-functional teams.
• Ability to make independent and objective decisions and to work with little to no supervision.
• Must possess an independent mindset.
• Independently completes complex tasks; completes routine tasks with 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 drives resolution with senior management oversight. 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 data and investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Deep 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 as Subject Matter Expert within the group, site and network.
• 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

• A Bachelor's degree in a biological science, engineering, microbiology or similar. An equivalent combination of education and experience will be considered.
• 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.

Work 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 for up to 10% of the time.
• Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.