Manager, Quality Assurance -Pharmaceutical

Allergan Plc Irvine , CA 92606

Posted 3 weeks ago

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results. All while wearing jeans to work!

Manager, Quality Assurance - Irvine, CA

WHAT YOUR NEW MANAGER WANTS YOU TO KNOW:

"I'm looking for a highly motivated and focused individual that can lead in a fast-paced Quality Assurance environment. Our products change people's lives every day and you should want to do the same. Our Manager, Quality Assurance will interact with clients across all aspects of the business"

  • YOU ARE more than just a title, YOU ARE Managing and administrating the BLI plant quality systems including CAPA, deviation, change control, OOS, complaint, and work order systems. Supporting any plant or corporate driven initiatives to enhance these systems.

    You are responsible for assessing and approving quality system documentation. This includes implementing and coordinating all activities relating to the control, distribution, maintenance and closure of GMP Quality documentation.

YOU WILL:

Be the BLI Quality Expert. You will present and defend quality management records and actions during FDA and Ministry of Health inspections and internal audits.

You will be responsible for quality records and systems within the Quality Management System (Trackwise) and you will be able to make final quality decisions on routine records while knowing when records require escalation to the Site Quality Head. You will manage the quality review function and ensure that all quality documents, including batch records, are reviewed in a timely manner, the review function will also be responsible for generation of APR's, stability reports, and other annual Quality Reports.

Be the Leader of QA Projects. Identify and update appropriate procedures to assist in the management of QA system to ensure closure and approval. Integration, preparation and distribution and review of product documentation, master batch records, media holds etc. to support operations and quality control departments consistent with corporate objective, GMPs, and regulatory requirements

Be the LMS and Documentation Leader. You will manage and administrate the plant GMP and Learning Management System (LMS) training program.

You will support any plant or corporate driven initiatives to enhance the training system. You will manage the Document Control Center and ensure that all necessary controls are in place for issuance, approval, and review of GMP documents. The position will ensure all relevant CORAL functionality is used and has been implemented as per corporate project plan.

YOU BRING:

  • BS degree in Chemistry, Biochemistry or related discipline or a combination of education and experience.

  • 5-8 years of related QA systems experience is required. Experience in Biotech or a Biopharmaceutical environment is highly desired.

  • A thorough understanding of cGMP regulations and experiences in regulatory inspection is required.

ALLERGAN LEADERSHIP SKILLS:

For this role, we're looking for a QA Leader who is:

  • Attention to Detail Focused

  • Quality Focused

  • Acts as an Owner

A Talent Magnet: The best leaders are brand ambassadors and have an eye out for great talent to join our family. All Allergan colleagues are an extension of our recruiting team, building bridges for the best people to grow our company.

WE WILL GIVE YOU THE ALLERGAN EDGE:

At Allergan, we define the "Allergan edge," as something that sets us apart, gives us an advantage and strengthens us to be better - for our customers, patients, investors and each other. Our 'edge' is our colleagues, and we are committed to making Allergan the best place for them to work and achieve career goals.

How do we do this? We Engage, Develop, and Reward our colleagues.

  • Engage. From Day 1.

    You are a bold leader who wants to make an impact. We listen to your ideas and your questions, so we can be even better at what we do.

  • Develop. Learn every day, build new skills every day. We prioritize development, so our leaders are always ready for the next challenge and opportunity.

  • Reward. Exceptional performance creates exceptional opportunities and rewards.

    Financial awards and incentives are just a part of this - we invest in our people; celebrate successes through recognition programs; promote healthy lifestyles and work-life balance. We offer amazing benefits most of which start on your 1st day at work (Medical, Dental, Vision, 401k - company match up to 8%, Tuition Reimbursement, and much more)

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Manager, Quality Assurance -Pharmaceutical

Allergan Plc