The Manager, Quality Control is responsible for the day-to-day oversight of analytical testing at contract laboratories and contract manufacturing facilities for testing on development and commercial pharmaceutical products and Active Pharmaceutical Ingredients (API). Interacts with internal multidisciplinary teams to ensure successful delivery schedules of analytical test reports or certificates. Assists with QC checks and preparation of regulatory filings (INDs and NDAs) and has a working knowledge of a variety of guidance documents from the ICH, FDA, and other global regulatory authorities. Manage projects associated with drug substance and products. |
1. Manage drug substance and drug product (commercial and CTMs) analytical testing at contract laboratories.
2. Manage stability activities including maintenance of master stability protocols and individual study plans, set up of stability studies, and assist in writing of timely stability reports.
3. Approve and issue component and/or drug product and packaged clinical trial material C of As.
4. Investigate and resolve analytical test failures (OOS and atypical results).
5. Monitor contract lab activities to ensure compliance and timeliness of C of As and reports.
6. Summarize and report laboratory performance metrics.
7. Manage various projects at contract laboratories.
8. Lead specification and method changes associated with Sunovion products.
9. Represent QC in cross-functional teams for Sunovion products and projects.
10. Assist in the preparation of Regulatory filings (INDs, NDAs, Supplements, and Annual Reports) including the writing of analytical testing sections.
11. Conduct trend analysis of data including writing Annual Product Review sections.
12. Review and approve various quality documents (internal and external) associated with Sunovion products.
13. Provide analytical support for manufacturing investigations as required.
14. Assist in maintaining the Sunovion LIMS.
15. Participate in vendor and internal audits.
16. Contribute to company quality systems.
Minimum education requirements
7 - 10 Years
Knowledge & skills (general and technical)
Knowledge of analytical testing concepts and principles such as Liquid Chromatography. Knowledge of current Good Manufacturing Practices (cGMPs) including laboratory controls and good documentation practices. Must be able to manage projects and work with cross-functional teams comprised of internal and/or external contacts.
Other requirements (licenses, certifications, specialized training, physical or mental abilities required)
Work hours are likely to include meetings scheduled outside of normal working hours. Demands during peak times may require work hours outside of normal business hours. Some travel is required.
All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best" industry practices and the highest ethical standards.
Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sunovion - 20 months ago