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Director Third Party Quality Management

Merck


Location:
Rahway, NJ
Date:
07/20/2017
2017-07-202017-08-19
Job Code:
QUA006044
Merck
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Job Details

Job Title: Director Third Party Quality Management  - QUA006044

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, 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 Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. 

 

The Director of Third Party Quality Management (TPQM), Development Quality is responsible for the overall operational and strategic oversight of third party contractors and vendors providing GMP manufacturing and analytical testing services in support of Merck’s clinical supply chain.  This position is responsible for a team of ~18 professionals.  Key areas of responsibility include: defining and driving the overall global process and system harmonization for Third Party Quality Management operations across all Merck R&D supply sites, directing the development and execution of a strategic global vision for TPQM in alignment with the Merck clinical supply chain and key stakeholders, ensuring the development, integration, execution and continuous improvement of third party quality processes globally to minimize and mitigate risk to Merck development programs.

 

The position will be heavily involved in ensuring close collaboration with the contractor quality and technical personnel and interacting with their functional equivalents in the source areas, e.g. drug substance and drug product manufacturing and testing, on strategic objectives utilizing external contractors, including GMP qualification as well as site/project selection.  This will be achieved via the direct management of a team of TPQM Contractor Liaisons serving as the bridge between TPQM and source areas, as well as between R&D and Commercialization activities, via maintaining a strong working relationship with commercial external quality management personnel.   

 

In addition to the high-level responsibilities discussed above, the incumbent is expected to independently execute on the following:

 

• Oversee the daily operational TPQM support for external contractors supporting Merck’s clinical development programmes including those performing manufacturing, testing, packaging/labeling, and distribution activities for drug substance.  Examples of activities include:  CAPA monitoring for audit observations issued to the external parties, tracking/trending and reporting of quality system performance via metrics, establishment and approval of intra-company and 3rd party Technical and Quality Agreements,

• Providing critical input and review of quality strategies, plans, organizational designs, standard operating procedures and process schemes ensuring overall timely execution in line with business drivers and objectives, e.g. including assurance of appropriate oversight of data used in clinical regulatory filings

• Ownership and management of the R&D aspect of the Approved Supplier List and associated changes / updates and liaison with source areas to continually monitor and rationalize the number of qualified vendors being maintained

• Maintain close relationship with Merck’s Divisional Auditing group in relation to audits conducted and mitigation activities in regard to audit observations

• Interacting cross-functionally and cross-divisionally with senior management on a wide array of topics involving quality/regulatory matters as well as special projects, and externally with inspectors and colleagues in industry.

• Coaching, mentoring and developing team members supporting their personal development and also colleagues in areas of expertise

• Directing the resolution of contractor / vendor related business practice, Quality and/ or compliance issues of broad scope and highest level of complexity on cross-functional and/ or cross-divisional basis.

• Identification of trends and/or potential compliance gaps and proactively leading the resolution of long-standing or significant issues affecting quality and efficiency.



Qualifications

Education Minimum Requirement: 

  • Bachelor Degree in Engineering, Biology, Chemistry or related field.

Required Experience and Skills:

  • A minimum of 10 years of relevant experience working within the pharmaceutical industry. Advanced Degree with 8 years relevant experience.
  • Experience interacting with regulatory officials and external auditing parties.

Preferred Experience and Skills:

  • Demonstrated leadership, strategy development and deployment experience in a pharmaceutical environment
  • Experienced and strong people manager with proven track record of developing talent
  • Proven track record of delivering tangible benefits from process improvement activities
  • Strong compliance knowledge  and understanding of regulatory agency regulations and requirements and interpretation and application re; GMPs to a R&D environment
  • Strong scientific/ technical expertise in R&D activities, coupled with the ability to interact with scientific subject matter experts on various product initiatives and issues
  • Possess deep drug development knowledge; demonstrated ability to facilitate training and learning with colleagues and apply knowledge to enhance the drug development process.
  • Demonstrated knowledge of continuous improvement methodologies; ability to direct complex cross-functional initiatives
  • Demonstrated experience in quality risk management in the Pharmaceutical industry
  • Strongly developed cross-functional teamwork, collaboration, influencing and negotiation skills
  • Strong demonstrated skills in communicating (oral and written) effectively with diverse individuals / groups

Your role at Merck 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 Merck, we’re inventing for life. 

 

If you need an accommodation for the application process please email us at staffingaadar@merck.com.

  

Search Firm Representatives Please Read Carefully: 

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

 

Visa sponsorship is not available for this position.

 

For more information about personal rights under Equal Employment Opportunity, visit:

 

            

            



Job Qual Assurance & Ops Generic

Primary Location NA-US-NJ-Rahway

Other Locations NA-US-PA-West Point

Employee Status Regular

Number Of Openings 1

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