QA Manager- Finished Goods Commercial

General Summary:

The Quality Manager provides oversight of department activities, ensuring alignment with corporate goals and regulatory requirements. This includes managing multiple complex projects, troubleshooting issues, and fostering collaboration with business partners and stakeholders to ensure the continuation of supply in all markets. The Quality Manager will also be responsible for overseeing and managing the end-to-end product disposition process for Finished Goods. This role ensures timely and compliant product release by overseeing data readiness and collaborating with Contract Manufacturing Organizations (CMOs) and internal teams to implement continuous improvement measures. The position reports to the Associate Director and plays a critical role in driving quality initiatives and maintaining the integrity of deliverables

KEY RESPONSIBILITIES

Key Responsibilities of the position may include, but are not limited to the following:

Product Disposition Management

• Oversee product disposition for Finished Goods, ensuring compliance with regulatory and quality standards.
• Collaborate with Contract Manufacturing Organizations (CMOs) to resolve disposition-related issues and align on timelines and quality expectations.
• Review of Executed Batch Records (EBRs) for commercial packaging operations and resolution of comments with CMOs
• Review of impacting change controls against full lot genealogy to determine if material is compliant in relevant region(s), make disposition decision, and perform batch release
• Evaluations of Investigations/ OOS/ Change Controls to support Disposition Decision
• Assist with EAC and Material Review Board activities, when necessary
• Manage data readiness for product disposition, including batch records, Certificates of Analysis (CoA), and supporting documentation.
• Proactively manage and improve disposition processes to meet turnaround times.

Stakeholder Collaboration

• Develop and manage relationships with strategic external partners in support of Vertex’s expanding commercial portfolio and manager ongoing relationships. As CMO lead, be responsible for management of QA relationships with one or more CMOs.
• Act as the primary QA contact for disposition-related queries and escalations.
• Collaborate with internal teams (e.g. MS&T, External Manufacturing, Supply Chain, Regulatory) to ensure alignment and timely resolution of quality events.

Compliance and Continuous Improvement

• Provide quality guidance for root-cause analysis, product impact assessments, and CAPA actions.
• Support GMP/GDP management reviews, risk assessments, and mitigation strategies.
• Identify and implement process improvements to enhance internal QA processes as well as Vendor performance.
• Lead and / or represent FG QA in cross-functional initiatives / continuous improvement projects.

Communication

• Prepare and present (as needed) operational and quality reports, including disposition performance metrics, trends, risks, and mitigation plans.
• Provide regular updates on disposition activities, CMO management and improvement initiatives.

Audit and Inspection Support

• Serve as SME responder and provide support for audit/inspection preparation, execution, and post-inspection activities.

MINIMUM QUALIFICATIONS:

• Bachelor’s degree in Life Sciences, Pharmacy, or a related health field.
• 4+ years of experience in pharmaceutical manufacturing (Packaging and Labelling Operations preferred), quality assurance, or Finished Goods product disposition.
• Strong knowledge of global GMP requirements and oral drug product manufacturing practices.
• Proficiency in data analysis and visualization tools.
• Excellent communication, collaboration, and project management skills.

PREFERRED QUALIFICATIONS:

• Strong leadership skills with the ability to thrive in a high throughput environment
• Attention to detail
• Critical Thinking / Problem Solving
• Ability to evaluate quality matters and make decisions utilizing risk-based approach
• Project Management / Continuous Improvement
  • Ability to lead and manage projects/teams within corporate objectives and project timelines
  • Proficient in utilizing project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks
  • Demonstrated ability to work independently to provide QA support for large, multifaceted projects
• Collaboration / Teamwork / Conflict Management
  • Ability to independently lead cross-functional teams and represent the Quality unit
  • Ability to understand and translate business needs
  • Recognized as a mentor with a strong ability to transfer technical knowledge and teach skills to junior staff
  • Represents Vertex Commercial Quality Assurance on cross functional working teams and is recognized for strong communication and influencing skills
• Flexibility/Adaptability
• Knowledge in the following areas:
  • Expert knowledge of global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices
  • GMP/GDP regulations and application to Manufacturing and Testing risk management principles
  • Root Cause Analysis tools/methodology
• Broad GxP Knowledge and understanding across lifecycle of the product
• Sense of urgency - ability to act quickly/escalation process/transparency