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Director, Supplier Quality Management

Stoughton, MA

At Collegium Pharmaceutical, we are building a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. We have a portfolio of meaningfully differentiated medications to treat serious medical conditions, including severe and persistent pain and ADHD.

Hybrid: Required to be onsite in Stoughton, MA on Tuesday, Wednesday and Thursday.

POSITION OVERVIEW

The Director, Supplier Quality Management will play a key role in the quality oversight of Contract Manufacturing Organizations and Contract Laboratories across the Collegium Product portfolio. This role is responsible for the GMP supplier management program which oversees contract manufacturing organizations, testing laboratories and material/service providers. This role will act as interdepartmental liaison to various groups including Manufacturing, Supply Chain and Regulatory Affairs. Additionally, this role manages the review, approval and trending of the QC data provided by our contract testing sites.  

RESPONSIBILITIES

  • Maintain the approved supplier list and the yearly audit schedule, internal and external.
  • Manage supplier performance scorecards and present supplier quality metrics to cross functional stakeholders.
  • Lead supplier performance metrics to monitor the health of systems, drive proactive identification of risk and mitigate compliance issues.
  • Lead the development and maintenance activities of Quality Agreements with GMP suppliers.
  • Lead technical assessments for deviations, investigations, OOS, anomalous results and change controls.
  • Ensure QC framework processes and policies/standards are established, implemented, audited, and continuously improved for the enterprise to ensure cGMP compliance with regulations and guidance documents.
  • Lead the QC data analytics, monitoring &trending program.
  • Provide quality support to CMOs & CTLs as needed during product related inspections.
  • Lead Annual Product Review (APR) activities.
  • Interface, as needed with Health Authorities in support of QC testing inquiries and supplier management activities.

REQUIRED LEADERSHIP BEHAVIORS 

Leadership Behaviors are a core set of behaviors that vary based on Level in the organization. We have categorized these under Head, Heart, and Guts.

  • Head
    • Know our Business
    • Think Critically
    • Decide
    • Execute
  • Heart
    • Collaborate
    • Develop
    • Communicate
    • Embrace Authenticity 
  • Guts
    • Be Disruptive
    • Innovate
    • Evolve
    • Be Tenacious

QUALIFICATIONS

  1. Minimum experience required: 10-15 years of pharmaceutical experience with a minimum 5+ years in Quality Control, Supplier Quality Management, or External Manufacturing
  2. Minimum education required: Bachelor’s degree in a relevant scientific discipline, Advanced degree preferred
  3. Minimum knowledge required: cGMP, USP/EP compendia and ICH testing requirements,
  4. Demonstrated knowledge of method transfers and qualifications/validations
  5. Strong written and oral communication skills as well as organizational skills
  6. Demonstrated leadership capability
  7. Ability to travel occasionally (up to 25%) to support project activities,
  8. Proven ability to conduct investigations, audits and develop presentations analyzing complex data.
  9. Well organized – a natural ability to be organized in how you think, communicate, and conduct your work.
  10. Ability to navigate through rapid growth and adapt to rapid change.
  11. Proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word) required.

Pay Range

$195,320 - $212,180 USD

Collegium is an equal opportunity employer. It is the policy of Collegium, in all of its relations with its employees and applicants for employment, to base all employment-related decisions upon valid job-related factors, without regard to age, national origin, citizenship status, ancestry, race, color, religion, creed, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or expression (including transgender status), sexual orientation, military or veteran status, physical or mental disability, genetic information, or any other status protected by applicable federal, state, or local law. This policy applies to hiring, training, promotion, compensation, disciplinary measures, access to facilities and programs, and all other personnel actions and conditions of employment. By this policy, Collegium seeks to ensure that all employees have the opportunity to make their maximum contribution to Collegium and to their own career goals. This policy provides for an equal employment opportunity program that will simultaneously serve the requirements of society, the law, sound business practices and individual dignity.

If you have questions or concerns about equal employment opportunities in the workplace, you are encouraged to bring these issues to the attention of the Head of Human Resources. We will not allow any form of retaliation against employees who raise issues of equal employment opportunity. To ensure our workplace is free of artificial barriers, violation of this policy may result in disciplinary action, up to and including termination.

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