|Reference # : ||18-37390
||Title : ||Sr Mgr QA Compliance - II //Foster City, CA with A Big Pharmaceutical Company|
Foster City, CA
|Position Type : ||Contract|
|Experience Level : ||
||Start Date / End Date : ||07/10/2018 / 02/19/2019
| Description |
|Job Title: Sr Mgr QA Compliance - II|
Work Location: Foster City, CA
Length of Assignment: 12 Months
Position Type: Contract Full Time
Client: A Big Pharmaceutical Company
Sr. Mgr QA Compliance
Essential Duties and Job Functions
Specific Responsibilities: The Senior Manager- QA Compliance, – will report to the Associate Director of Supplier Management and Auditing. This key position will conduct GMP/GDP audits for in support of the global audit program. This position will contribute to and support the effectiveness of the global audit program. This position will also support serialization based audits conducted in preparation for the implementation of the EU Falsified Medicines Directive to become effective in Feb of 2019.
? Conduct global vendor audits for such for GDP/GMP providers including warehouse / distribution centers, third party logistics providers, and Affiliate offices in support of clinical and commercial oral and parenteral dosage formulations and associated medical devices.
? Manage all aspects of the audit lifecycles: scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CA/PA, and closing.
? Ensure that the audit agenda is risk-based and has the appropriate internal and/or external subject matter experts as part of the audit team.
? Work directly with cross-functional departments to gather key information and feedback for conducting vendor audits
? Identify compliance risks and escalate issues to appropriate levels of management for resolution.
? Drive consistency with audit report observation classification, status and overall risk
? Conduct due diligence assessments as part of global expansion
? Identify and drive program improvements
? Other responsibilities as required.
? Supports Compliance management in maintaining the company's Compliance program.
? Responsible for maintaining current knowledge of applicable compliance requirements through attendance at industry and regulatory agency sponsored meetings and seminars.
Knowledge, Experience, and Skills
Demonstrates excellent verbal, written, and interpersonal skills
Demonstrates a thorough knowledge of compliance requirements and an understanding of current global and regional trends in compliance
10+ years of relevant experience in the pharmaceutical industry and a BS or BA
8+ years of relevant experience and a MS
Travel is required up to 60% both international and domestic.
If you are interested in this job than please send me your most updated resume on firstname.lastname@example.org or you can reach me at #973-507-7579