Associate Director, CMC Compliance

1 week ago

Boston, United States Vertex Pharmaceuticals Incorporated Full time

Job Description

General Summary:

The Associate Director, CMC Compliance is responsible for proactively and comprehensively monitoring vendor quality and compliance risk for vendors participating in GxP regulated environments across product modalities. This position is responsible for developing, maintaining, and disseminating vendor data and analytics, including but not limited to vendor key performance indicators, vendor quality metrics, and a vendor risk scorecard, to QA and to key business partners at the enterprise and program levels. The role also drives continuous improvement in Vertex vendor quality processes and governance to assure Vertex remains adherent to regulatory expectations and supports QA operational quality oversight and management of complex vendor issues.

Key Duties and Responsibilities:

  • Maintains and manages an innovative and risk-based model for quality oversight and management of GxP vendors across product modalities.
  • Maintains up-to-date integrated quality and risk scorecards across GxP vendors.
  • Partners with Quality and business stakeholders to ensure adequate quality processes, governance and quality oversight across GxP vendors.
  • Serves as a consultant to Vertex QA teams and business functions in identifying risk management strategies, selecting vendors and remediating complex vendor issues.
  • In close partnership with Quality and business stakeholders, maintains and evolves vendor quality-related processes, procedures, and templates.
  • Monitors vendor metrics and dashboards for emerging trends across vendors and communicates insights to appropriate QA and business stakeholders.
  • Drives awareness and application of evolving regulatory requirements and expectations for vendor management across GxPs and product modalities.
  • Partners with QA operational, audit, and inspection teams in sharing and aligning on risks, managing complex quality issues, implementing process improvements and driving quality outcomes, including inspection readiness.
  • Serves as an SME and participates in inspection preparation and management activities relevant to vendor processes, risk management and oversight.
  • Identifies quality improvements to Vertex quality systems to maintain compliance and improve efficiency utilizing risk-based methodologies, as related to vendor management/vendor oversight.

Knowledge and Skills:

  • Demonstrated working knowledge and experience applying US and international/global regulatory requirements, associated guidance and standards applicable to drug, biologic, combination product, and/or device research, development, manufacturing, and distribution.
  • In-depth knowledge of regulatory requirements specific to vendor selection and oversight in one or more GxP areas.
  • Strong working knowledge of risk management and issue management, with a demonstrated ability to apply to third party suppliers carrying out GxP governed activities.
  • Strong oral and written communication and interpersonal skills to communicate difficult concepts and persuade others.
  • Strategic "big picture" thinking while maintaining ability to collaborate effectively and execute efficiently at a tactical level.
  • Strong analytical thinking skills, with the ability to translate data into risk-informed insights that drive decision-making.
  • Experience advising, coaching or mentoring junior staff.

Education and Experience:

  • Bachelor's degree in a scientific or allied health field (or equivalent degree).
  • Typically requires 8 years of relevant work experience, or the equivalent combination of education and experience.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

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.

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