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Associate Director, Quality Control

Semma Therapeutics

Semma Therapeutics

Quality Assurance
Boston, MA, USA
Posted on Wednesday, February 7, 2024

Job Description

General Summary:

The Associate Director, Quality Control fully manages and directs the technical support function in the Release and Stability Laboratory (RSL) QC department supporting validation, testing and reporting of in-process, release and stability samples. The role is responsible for leading other QC personnel, optimizing Department resource allocation according to project/program needs to assure testing activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values.

Key Duties and Responsibilities:

  • Full responsibility to oversee laboratory program(s)/processes for Laboratory deviations/investigations, change controls, and method validations/transfers
  • Provide leadership in the coordination, management, and prioritization of laboratory activities
  • Work with internal and external partners to ensure laboratory activities are scheduled and prioritized to meet commitments on-time
  • Serve as QC representative/SME in cross-functional, cross-departmental working teams and/or working with outside vendors to meet all laboratory needs
  • Establish and communicate performance objectives for staff that are consistent with department, site and company goals
  • Ensure all lab personnel have adequate training, education, and experience to perform their GMP related job function effectively
  • Leads planning and coordination of method validations, and method transfers
  • Reviews, and/or approve data, SOPs, COAs, analytical methods, protocols, reports, OOS/OOT investigations and deviations
  • Monitor, track and publish lab metrics for the department and take actions as necessary
  • Provides developmental feedback and coaching to direct reports to create a collaborative environment that attracts, develop and retains personnel
  • Leads compliance and efficiency related teams working towards the goal of continuous improvement to increase value and efficiency

Knowledge and Skills:

  • Extensive knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher and applying/interpretation of GMP requirements
  • Expertise in method validations/transfers
  • Experience in building, growing and leading a high performance team
  • Strong knowledge of US and EU cGMP regulations/guidance and experience with regulatory agency inspections.
  • Effective communication skills, both verbal and written
  • Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail

Education and Experience:

  • Bachelor Degree in science or related discipline is required
  • 10 years of experience in pharmaceutical/biopharmaceutical industry with 6 years of increasing management responsibility, or the equivalent combination of education and experience

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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.