Senior Director of Quality

We are seeking an experienced Quality professional to be a key member of our dynamic, fast-paced organization. The successful candidate for the position of Senior Director of Quality will be responsible for supervising the activities of the Quality Assurance (QA) and Quality Control (QC) teams and will report directly to management.

The position responsibilities include maintaining and growing the company’s quality systems and ensuring compliance with company and regulatory policies and requirements. Applicants must have demonstrated experience with all aspects of directing QA/QC activities related to manufacturing purified proteins under cGMP standards for production of clinical trial materials. In addition, writing and reviewing protocols, batch records and other GMP documentation will be required. The candidate must have the interpersonal and communication skills necessary to effectively manage multiple direct and indirect reports as well as interact with management, the Manufacturing team and client partners.

Preferred Requirements:
- BS/PhD in an applicable field with 10+ yrs industrial experience in QA/QC
- A breadth of expertise with Quality Systems for early phase clinical trials, including change control, documentation, QA investigations, vendor qualification
- Expertise in various QC activities such as developing and qualifying QC and release assays, environmental monitoring, OOS investigations, raw materials sampling
- Experience with cGMP manufacturing of biologic therapeutics
- Proven ability to conduct vendor audits and host client and regulatory audits
- Knowledgeable with current regulatory requirements for early phase clinical trials
- Capacity to work on complex assignments of diverse scope and ability to exercise judgment within defined procedures and practices to determine appropriate actions
- A demonstrated managerial track record

To be considered as an applicant, please submit your resume/CV referencing the specific position of interest to careers@pacificgmp.com. In addition, please provide at least 3 professional references, preferably from superiors. Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. Candidates will only be contacted for evaluative discussions. EOE.