Description
This role is with an exciting mid sized Pharmaceutical company here in the Bay Area. We are looking for someone with strong CMO management skills and a broad base of international experience. Here are a few key responsibilities:- Provide Quality oversight of contract manufacturers and distribution centers to support the global supply of commercial and clinical drug products. Includes review/approval of packaging and labeling documents.
- Review/approve executed batch records and analytical data to support QA disposition.
- Lead failure investigations in collaboration with contract manufacturers and follow-up on corrective actions.
- Assess deviations/OOS/OOT/CAPAs for compliance and completeness.
- Provide QA investigational support related to Product Complaints
- Lead Change Control Review Board Meetings.
- Drive ongoing continuous process improvement initiatives to improve existing Commercial Quality Systems (e.g., Label Control, Change Control, Discrepancy Resolution, and CAPA).
- Support ongoing initiatives to optimize existing Commercial Packaging/Labeling Systems.
- Provide data trends on a quarterly basis for incorporation into Management Review presentations.
- Participate in FDA and other regulatory agency inspections as needed.
- Participate in Project Team meetings and provide QA support as needed.
Requirement:
- BS/BA in a scientific discipline with a minimum of 8-10 years of experience in the pharmaceutical industry.
- At least 3 years of supervisory/management role experience
- Experience with virtual manufacturing and packaging processes for solid dosage forms.
- Experience with clinical labeling processes and blinded/unblinded records.
- Thorough knowledge of US and EU current Good Manufacturing Practices (cGMPs) including ICH guidelines for a global market.
- Approximately 15% domestic and international travel.
- Proficiency with electronic Quality Management Systems (e.g., Trackwise) a plus.
- Strong analytical and problem solving skills.
- Excellent verbal, written, and interpersonal communication skills.
- Must be able to work collaboratively across departments and with external vendors and contractors.
If this seems like an opportunity that fits your skill set and what you are looking for, please contact me at b.ross(@)realstaffing.com to apply right away! Thank you
To find out more about Real please visit www.realstaffing.com