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Associate Director, Supplier Quality Assurance Job

Date: Nov 21, 2017

Location: Unterschleißheim, BY, DE

Company: MSD

Requisition ID: QUA006247

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare

For our team in Unterschleißheim near Munich we are looking for a highly motivated and qualified

Associate Director, Supplier Quality Assurance

The primary purpose of the position is to help ensure that all products or materials supplied to MSD Animal Health from a set of key suppliers are manufactured, packaged, analyzed and distributed in conformance to company and regulatory guidelines and meet both internal and external customer demands.

The incumbent is responsible for supporting total quality performance and operations of such Third Party Operations through direct support and technical advice, guidance, counselling to the site Quality Operations Manager or Director. The incumbent exercises a coaching role in guiding the Third Party to comply with Current Good Manufacturing Practices regulations and other pertinent legal requirements.

Responsibilities:



  • Reports to the Director, Supplier Quality Assurance for External Manufacturing (Animal Health) and is a member of the Quality External Manufacturing team. Receives guidance and direction when necessary; discharges all responsibilities independently. Keeps the Director informed on the status of operations and when challenges, opportunities and/or issues arise.

  • Is conversant with the technology and regulatory framework that the supplier operates under.

  • Assures that the partner operates within the agreed upon GMP policies and procedures (or other applicable regulations) and in accordance with the Quality elements of the Commercial Agreement and the Quality Agreement; ensures the Quality Agreements / Change Agreements are kept up to date and ensures review of the Quality elements in the Commercial Agreement

  • Acts as MSD-AH Quality Operations point of contact to defined key suppliers and as the Quality liaison between the external partner and the internal company personnel.

  • Supports MSD Animal Health audit plans and effective execution of subsequent remediation by the partner; may also perform separate audits

  • Conducts regular site visits to support training and coaching to initiate quality improvements within the partners’ Operations where necessary.

  • Assures Quality requirements on Change Proposals submitted by the partners conform to all requirements.

  • Reviews all Deviation investigations submitted by the partners and supports further investigation where necessary.

  • Support Product Quality Complaint (PQC) investigations with the relevant suppliers

  • Support Technology Transfer projects for the relevant suppliers

  • Assures guidance is provided to the partner in the preparation of Quality Systems, procedures and guidelines as applicable

  • Support effective preparations at the third party for regulatory inspections (where required).

  • Effectively contributes to cross-functional investigations and project teams.

  • Reviews batch documentation and data to support batch release activities when appropriate and may be required to provide QP certification

  • Maintains Quality metrics as required

  • Completes additional Quality related activities as required to fulfil the role
Qualifications


  • Qualifications, Skills & Experience

  • Bachelor degree in Veterinary, Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering (or equivalent)

  • Must have Qualified Person eligibility

  • Must have expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements

  • Must have English language capability preferably with a second language

  • Must have excellent problem solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments; must be able to apply sound risk management;

  • Must have the ability to influence management of complex manufacturing operations, protecting company image and reputation with patients, medical stakeholders and regulatory agencies.

  • Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, sterile operations, cGMPs and regulatory issues

  • Must have strong demonstrated interpersonal, communication, negotiation, persuasion and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations. Able to handle organisational complexity and ambiguity

  • Preferably to have Auditor training (example ISO 9001)

Leadership Behaviors
include



  • Focus on Customers and Patients

  • Make Rapid, Disciplined Decisions

  • Act with Courage and Candor

  • Build Talent

  • Demonstrate Ethics and Integrity

  • Drive Results

  • Foster Collaboration

If you are interested in this position please apply via Taleo.


 


Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.



Job: Qual Assurce - 3rd Party Manuf
Other Locations:
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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