Manager, Quality Assurance
$120k - $141k USD
Collegium Pharmaceutical is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. We have a leading portfolio of responsible pain management and neuropsychiatry medications.
Hybrid: Required to be onsite in Stoughton, MA on Tuesday, Wednesday and Thursday.
POSITION OVERVIEW
The Manager, Quality Assurance will be responsible for supporting the manufacturing, testing, and release of drug products for clinical and commercial use. They will ensure compliance with all aspects of 21CFR §210, §211, and §820 cGMP. This role will be responsible for providing leadership in the management of critical quality systems (i.e. : Batch Disposition, Investigations (Deviation / Product Complaint), CAPAs, Change Control, etc. ) that allow the company to maintain all licenses to operate. This individual will be critical in supporting interdepartmental and cross functional project management activities.
RESPONSIBILITIES
- Develop, review, and approve company documentation including Standard Operating Procedures (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’ (Contract Manufacturing Organizations (CMOs), Contract Testing Laboratories, etc.) Quality Assurance departments
- Review and approve or reject bulk drug product, and packaged/labeled products per established 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
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
- 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 required
- Experience in implementation and administration of quality systems for drug development, manufacturing and quality control operations.
- Strong verbal and written communications skills.
- GCP experience and/or controlled substance experience a plus
Pay Range
$120,000—$141,440 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.