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Manager, GMP Operational Quality (Hybrid)

Semma Therapeutics

Semma Therapeutics

Quality Assurance
Boston, MA, USA
Posted on Thursday, February 1, 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 Finished Goods. 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:

  • Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions
  • Responsible for oversight of analytical activities in support of release and validation activities for Commercial Finished Goods. This includes analytical data review and COA generation and approval.
  • Lead root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified
  • Perform change control assessments and closure approvals
  • Establish and revise Quality Agreements between CMOs/Suppliers and Vertex, as needed
  • Responsible for QA oversight of analytical methods’ qualification and transfer, ensuring compliance.
  • Collect data and report on metrics
  • Represent Vertex Quality on cross-functional working teams, applying strong communication and collaboration skills.
  • 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, and assists in preparation of audit responses, as needed.
  • May manage personnel and provide oversight of day-to-day operations.
  • May assist with workforce planning/resource modeling and update through forecasting activities.
  • Lead continuous improvement projects
  • Author SOPs to support commercial quality functions.
  • Assist with regulatory agency inspections
  • Identify and facilitate continuous improvement efforts

Knowledge and Skills:

  • Good understanding of both the conceptual and practical application of cGMPs in a pharmaceutical setting
  • Proven experience leading a variety of straightforward projects/teams within stated objectives and timelines.
  • Ability to communicate effectively with cross-functional team members, exchanging complex information and influencing/guiding others to understand a stated viewpoint
  • Ability to manage own workload to achieve goals and seek opportunities to share information and help others understand technical processes
  • Formal project management experience
  • Strong communication skills (written and verbal) with the ability to communicate with a variety of audiences.
  • Able to integrate activities with other groups, departments, and project teams as needed.
  • Demonstrated ability to evaluate quality matters and solve problems leveraging technical experience and advanced judgment to select appropriate solutions
  • Excellent team player and collaborator
  • Highly proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA
  • Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva)
  • 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
  • Advanced knowledge of GMP regulations, regulatory requirements, and applicability to duties.

  • Operational QA experience in analytical or manufacturing settings, interpretation, and application of GMPs and applicable guidelines/guidance ex. ICH, USP, etc.

  • Knowledge of basic analytical techniques (e.g., HPLC, dissolution, GC, KF, etc.).
  • Knowledge, and application of risk management principles/ Risk Impact evaluation-aligning effort to level of risk.
  • RCA tools/methodology/ technical writing.
  • Facilitation/problem-solving/organizational, planning, etc

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-AR1 #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 ApplicationAssistance@vrtx.com.