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 role also oversees end‑to‑end product disposition for finished goods, ensuring timely and compliant product release by managing data readiness and collaborating with contract manufacturing organizations (CMOs) and internal teams to implement continuous improvement measures.

• Product disposition management for finished goods, ensuring compliance with regulatory and quality standards.
• Collaborate and resolve disposition‑related issues with CMOs, aligning timelines and quality expectations.
• Review executed batch records (EBRs) for commercial packaging operations and resolve comments with CMOs.
• Evaluate change controls against lot genealogy to determine compliance, make disposition decisions, and perform batch release.
• Support investigations, OOS and change controls to support disposition decisions.
• 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 improve disposition processes to meet turnaround times.
• Develop and manage relationships with strategic external partners and maintain QA relationships with one or more CMOs.
• Act as the primary QA contact for disposition‑related queries and escalations.
• Collaborate with internal teams (MS&T, External Manufacturing, Supply Chain, Regulatory) to resolve quality events.
• 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 and vendor performance.
• Lead or represent FG QA in cross‑functional initiatives and continuous improvement projects.
• Prepare and present operational and quality reports, including disposition performance metrics, trends, risks, and mitigation plans.
• Provide regular updates on disposition activities, CMO management and improvement initiatives.
• Serve as SME responder for audit/inspection preparation, execution and post‑inspection activities.

• 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.

• Strong leadership skills and ability to thrive in a high throughput environment.
• Attention to detail, critical thinking, and problem‑solving skills.
• Ability to evaluate quality matters and make decisions using a risk‑based approach.
• Project management and continuous improvement experience, including leading and managing projects/teams, using project management tools, and facilitating completion of tasks.
• Ability to independently lead cross‑functional teams, represent the Quality unit, and communicate influences.
• Mentor ability with strong technical knowledge transfer to junior staff.
• Expert knowledge of GMP requirements governing oral drug products and related manufacturing practices, GMP/GDP regulation application, root‑cause analysis tools, broad GxP knowledge.
• Sense of urgency and ability to act quickly with escalation process transparency.

The role provides a competitive compensation package including an annual bonus, annual equity awards, potential eligibility for overtime pay in accordance with federal and state requirements, comprehensive medical, dental, and vision benefits, paid time off with company shutdowns, educational assistance programs, student‑loan repayment support, a commuting subsidy, charitable donation matching, a 401(k) plan, and other inclusive market‑leading benefits.

$118,400 – $177,600. Salary is based on skills, experience, and job‑related factors.

Vertex is an equal opportunity employer. Vertex is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants. Vertex is an E‑Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.