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Manager, GMP Operational Manager Analytical QA (Hybrid)

Semma Therapeutics

Semma Therapeutics

Quality Assurance
Boston, MA, USA
Posted on Wednesday, April 10, 2024

Job Description

General Summary:

The Manager for Operational GMP QA is a technical resource in the principles and application of quality assurance and compliance. The Manager leads the coordination of GMP QA Analytical activities in support of release of Commercial Drug Product. The Manager coordinates and/or executes activities on multiple complex projects and takes a role in the design and execution of new projects. The Manager adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with regulatory requirements. May manage and develop personnel to support department and functional activities. This role is a Hybrid Role and holds the requirement to be on site 3 days a week, with the option to work remotely 2 days per week.

Key Duties and Responsibilities:

  • Collaborates with internal and external business partners to resolve quality issues to ensure compliant solutions in support of QA Analytical function.

  • Responsible for oversight of analytical activities in support of release and validation activities for Commercial Drug Product (DP). This includes analytical data review and COA generation and approval.

  • Participates in cross-functional teams as an experienced Quality technical resource.

  • Assists Change Control owners with ensuring compliance with regulatory and procedural requirements. Assesses and approves change controls for implementation and closure.

  • Guides and conducts quality investigations /OOS investigations, deviations and reviews corrective action plans for adequacy and compliance.

  • Leads root-cause analysis and product impact assessment.

  • Ensures appropriate CAPA actions are identified and addressed. Approves investigations/CAPAs.

  • Responsible of QA oversight of analytical methods’ qualification and transfer, ensuring compliance.

  • Collects, maintains, and reports Quality Metrics.

  • Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed.

  • Work with suppliers to ensure inspection readiness.

  • Identifies, facilitates, and/or leads continuous improvement efforts.

  • Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and method reports.

  • Identifies and communicates risks and assists with risk mitigation plans as necessary.

  • Provides support for audit or regulatory inspections, assists in preparation of audit responses, as needed.

  • May manage personnel and provide oversight of day-to-day operations.

  • May assists with workforce planning/resource modeling and to update through forecasting activities.

Knowledge and Skills:

  • Good understanding of both the conceptual and practical application of cGMPs in a pharmaceutical setting. Understanding of global GMP requirements and support of GMP manufacturing and testing.

  • Demonstrated ability to evaluate quality matters and solve problems leveraging technical experience and advanced judgement to select appropriate solutions.

  • Strong communication skills (written and verbal) with the ability to effectively communicate with cross functional team members, exchanging complex information and influencing/guiding others to understand a stated viewpoint.

  • Proven experience to plan and manage workload to achieve goals. Ability to work in a fast-paced environment and meet quality, accuracy and timeliness objectives.

  • Strong experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA.

  • Strong experience with electronic quality management systems.

  • Strong knowledge of analytical techniques (such as HPLC, GC, KF, etc.,).

  • Strong team communication skills with the

  • Experience using project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks.

  • Experience leading complex projects/teams and continuous improvement initiatives within stated objectives and timelines.

Education and Experience:

  • Bachelor's degree in scientific or allied health field (or equivalent degree)
  • Typically requires 4 years of experience, or the equivalent combination of education and experience
  • Operational QA experience in analytical or manufacturing setting, interpretation, and application of GMPs and applicable guidelines/guidance’s ex. ICH, USP, etc.
  • Advance knowledge of GMP regulations, regulatory requirements and applicability to duties.

    Hybrid-Eligible Roles

    In this Hybrid-Eligible role, you can choose to be designated as:

  • Hybrid: work remotely up to two days per week; or select
  • On-Site: work five days per week on-site with ad hoc flexibility.
  • #LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. 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.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at