Job Description

DAP Quality Assurance Manager – West Chester, Ohio

My client is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

Position Summary

The Manager, Quality Assurance will be accountable for all QA activities and decisions to directly support GMP production operations in a Process Execution Team (PET). These activities and decisions include change control, technology transfer and project support, documentation, equipment and process validation, deviation investigations, SOPs, and regulatory interactions and may also include medical device management support. This role will evolve to provide leadership, daily support, and supervision of GMP operations. The Manager, Quality Assurance will develop a quality support program for technical projects programs to support GMP manufacturing, and the training of QA personnel, and also be responsible for overseeing the daily activities of QA staff.

Position Responsibilities

• Develops and maintains a high level of understanding of the technical production process and quality systems being utilized within the Process Execution Team (PET)
• Accountable for all QA decision-making in the PETs; works with the PET leaders and other team members to deliver all PET and site objectives.
• Provide direction, development, and performance management to the Quality professionals supporting the PET.
• Accountable for the QA review and approval of the following GMP documentation that has a direct impact on the activities performed by, and the equipment and facilities utilized by the PET:
• Change Management (Change controls)
• Quality Investigations (Deviations, supplier deviations)
• Support Technical Transfers, Validation Plans, Protocols, and other technical reports.
• Standard Operating Procedures & Risk Assessments
• Medical device management and support
• Accountable for the release of incoming materials (bulk, APIs, excipients, packaging components, and so on.)
• Team management
• Support the site to ensure a safe working environment, including leading your team's safety efforts.
• Supervise, coach, and assist with employee development and performance management; ensure a fair and equitable workplace.
• Collaborates with other managers and Quality professionals from other PETs (including other sites) to ensure consistent application of the key quality systems across all PETs.
• Interfaces with the Site Support Groups on improvement projects (capital and noncapital) that impact the PET, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projects.
• Work cross-functionally with the area process teams for metrics reviews, operational support, and issue/deviation management.
• Ensures that PET complies with all GMP Compliance and Regulatory requirements by providing proper coaching, mentoring, and consultation to the PET leader and PET members.
• Ensures that the QA processes including batch documentation review, product disposition, and quality issues resolutions are executed to maintain the flow of products and documents to meet organization objectives.
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the workgroup.

Minimum Qualifications

• Experience in a position of people leadership
• Advanced knowledge of cGMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies
• Ability to influence leaders in a matrix environment, as well as the personal conviction to make courageous decisions to ensure patient safety and safeguard the company's reputation.

Preferred Qualifications

• Five years of experience in supervisory/managerial roles within QA in the Pharmaceutical Industry
• Advanced degree, bachelor's degree or higher
• Multiple site or functional experience
• Experience with medical device regulations
• Demonstrated problem-solving and decision-making skills
• Ability to direct and participate in cross-functional teams.
• Advanced knowledge of regulatory agency interactions and compliance procedures, with the ability to apply the knowledge in an operation environment

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