QA Manager- Finished Goods Commercial

Vertex Inc.•Boston, MA

3d•$118,400 - $177,600•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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
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
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
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

Responsibilities

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