Collegium Pharmaceutical is hiring a Manager, Quality Assurance to support the manufacturing, testing, and release of drug products for clinical and commercial use. You will ensure cGMP compliance and provide leadership for critical quality systems like Batch Disposition, Investigations, CAPAs, and Change Control while supporting interdepartmental project management.
What You'll Do
- Develop, review, and approve company documentation including SOPs, Analytical Test Methods, Product Specifications, Change Controls, Validation Protocols, Validation Reports, and Master Batch Records.
- Provide Quality review, impact assessments, and approvals for product investigations (Product Quality Complaints or manufacturing/lab investigations).
- Liaise with vendors’ Quality Assurance departments (CMOs, Contract Testing Laboratories, etc.).
- Review and approve or reject bulk drug product and packaged/labeled products per specifications and determine final disposition of clinical and commercial manufactured products.
- Represent the Quality organization to internal and external stakeholders.
- Inform Quality management of issues and progress of assigned projects.
- Perform internal audits and external audits of contract labs, CMOs and/or CROs.
- Manage controlled substances inventory and destruction.
- Perform Annual Product Reviews.
- Assist with development and maintenance of Quality Agreements with suppliers.
- Assist with FDA inspections, other regulatory inspections, and audits.
What We're Looking For
- BS degree in Pharmaceutical or Life Science with a minimum of 4-6 years of QA experience in pharmaceuticals or biologics.
- Demonstrated strong knowledge of cGMPs and high attention to detail.
- Experience with Batch Review and Disposition, or product quality complaint investigations.
- Experience in pharmaceutical Quality Assurance management including the ability to identify and resolve compliance issues, make independent decisions, demonstrate good judgment in escalating issues, and drive change in quality programs throughout the organization.
- Experience in implementation and administration of quality systems for drug development, manufacturing, and quality control operations.
- Strong verbal and written communications skills.
Nice to Have
- GCP experience and/or controlled substance experience a plus.
Work Mode
This is a hybrid role based in Stoughton, MA.
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.
