Director GMP QA - CMO management 8/11/2016

KHI South San Francisco, CA

Company
KHI
Job Classification
Full Time
Company Ref #
28722380
AJE Ref #
575854118
Location
South San Francisco, CA
Job Type
Regular

JOB DESCRIPTION

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Director GMP QA - CMO Management

South San Francisco, CA

A commercial biopharmaceutical company is hiring. With a deep pipeline in the CNS space, we are seeking to hire a skilled GMP QA professional as we advance clinical trials into late phase studies and approach commercialization of new compounds. Most of our research occurs in the USA & EU and drug manufacturing including API throughout the USA, EU & Asia.

Responsibilities

* Oversee GMP operations at CMOs including quality review of batch records, analytical data, and lot disposition activities of API, Bulk drug product, packaged and labeled drug products to support clinical and commercial.
* Manage quality investigations at CMOs including OOS/OOT and deviation investigations and ensure timely closure consistent with SOPs and regulations.
* Review and approve documents such as specifications, protocols and reports (process validation, analytical method validation, stability, labeling and packaging, etc.)
* Manage internal deviations, CAPA and change control.
* Provide quality oversight for technical transfer activities (process and analytical method transfer).
* Coordinate and perform external GMP audits of contract vendors and participate in vendor qualification activities. Write auditreports and manage closure of audit observations.
* Develop and revise SOPs as needed.
* Assist with risk-based approaches to promote internal and external GMP quality.
* Participate in the preparation and review of CMC sections of regulatory submissions.
* Maintain GMP quality documentation files, databases and logs. Track quality metrics and trends.
* Work with the VP of Quality to assure alignment and compliance with the company quality management systems.
* Act as a key internal resource, providing information and expert guidance on GMP regulations.
* Coordinate and prepare for Pre-Approval inspections at CMOs.

REQUIREMENTS:

* 7-10years in pharmaceutical GMP Quality Assurance.
* At least 3-5years of experience in managing QA activities in scale-up, registration, validation and/or commercialization.
* Experience with Pre-Approval Inspections (domestic and foreign).
* Experience with small molecule API and DP processes in a contract manufacturing and testing environment.
* In depth knowledge and understanding of US and EU GMPs, ICH guidelines, EU QP release requirements
* Strong GMP auditing experience.
* Travel approximately 10-20%.

* Ability to advocate a quality environment and effectively interface with API and DP and Supply Chain partners.
* Outstanding analytical, organizational, written/verbal communication skills

Core Competencies:

pharmaceutical quality assurance, regulatory compliance, GMP, current good manufacturing practices, solid dosage, tablet, API, PAI, pre-approval inspection, CMO, contract manufacturing, vendor management, small molecule, auditing, clinical material, commercial production, 21 cfr part 210, 21 cfr part 211, ICH guidelines