Manufacturing Quality Leader

Job Summary:
The Manufacturing Quality Leader is responsible for maximizing organizational learning and improvement from high-risk quality events. This role ensures that analytical cause analysis techniques and human organizational performance principles are applied to each investigation within the site. The incumbent leads the site team responsible for conducting and documenting quality investigations and is accountable for coaching and developing the team. Collaborating with stakeholders across all business areas, the Manufacturing Quality Leader ensures that actions taken as a result of events prevent or mitigate the risk of future recurrence. This position ensures effective communication to stakeholders and manages activities to ensure completion per expected regulatory and product release timelines. The incumbent provides guidance for the organization’s investigation standards, ensures investigations align with Pharmaceutical Quality System requirements, and presents investigative findings during audits as requested.
Principal Accountabilities:

1. Lead Quality Investigations:
   • Direct the team in conducting and documenting quality investigations, focusing on performance improvement and risk reduction in alignment with the Quality Management System requirements.
   • Directly support and/or conduct complex and high-impact investigations.
2. Team Management and Development:
   • Manage team workload to ensure investigation standards and due date requirements are met.
   • Develop team skills and provide guidance on investigation standards.
3. Coordinate Sharing of Findings and CAPA Process:
   • Facilitate internal sharing of investigational findings.
   • Ensure a robust Corrective and Preventive Action (CAPA) process to mitigate root causes and implement learnings to the shop floor.
4. Provide Subject Matter Expertise:
   • Offer expertise in enterprise risk evaluations and performance improvement strategies owned by Product Operations & Technology (PO&T) line functions.

Minimum Education Requirements:

• Bachelor’s degree in Engineering, Organizational Psychology, Forensics, or a related scientific discipline.

Minimum Experience Requirements:

• 10-15 years of experience in a laboratory and operations environment, in industrial  GMP settings.

Scope/Accountability:

• Oversee quality investigations for manufacturing and non-manufacturing sites.
• Lead and develop a team of Subject Matter Experts (SME) for conducting and documenting investigation findings and related actions.
• Contribute to internal standards for quality investigations in alignment with Pharmaceutical Quality System (PQS) requirements.
• Collaborate cross-functionally to ensure effective communication, sharing of learnings, and prioritization of work.
• Work across sites to maintain alignment on process and system improvements resulting from investigative findings and/or risk analyses.

Impact/Influence/Liaison:

• Partner with all PO&T functions to ensure thorough investigations and resulting actions to eliminate or reduce the risk of recurrence.
• Manage complex situations, including stakeholder management related to significant, high-risk incidents and events, inclusive of regulatory expectations.
• Provide direct input to site leadership teams on risk and reliability.

Decision Making, Discretion & Latitude:

• Provide exceptional technical leadership and guidance to professional staff.
• Direct and coordinate activities related to quality investigations to meet business, safety, and reliability objectives within the region.
• Review and approve investigation reports generated by the team.
• Confer with functional heads on critical decisions, identification of issues, and problem resolution to ensure concurrence and operational impact, especially concerning high-risk investigations.

Knowledge & Skills:

• Demonstrated experience in key technical facets of the role.
• Strong coaching skills with a proven record of effectively leading and developing teams.
• Experience in identifying and managing diverse stakeholders with strong interpersonal and influencing skills.
• High level of personal credibility and relationship management.
• Ability to communicate effectively across organizations and balance resource demands from multiple internal customers.
• Demonstrated experience in analytical cause analysis and performance improvement.
• Practical knowledge and application of cGMP, cGLP, and EMEA compliance regulations and inspections, with experience interfacing with inspectors, investigators, and/or agency personnel.
• Strong interpersonal skills, including the ability to negotiate and resolve challenges with poise, tact, and diplomacy.
• Strong oral and written communication skills across all employment levels and to PO&T Senior Leadership.
• Demonstrated ability to analyze, extrapolate data, synthesize, and determine recommendations, including the analysis of complex problems.