Associate Director, Quality Systems

Employer
Location
West Point, PA, USA
Salary
Competitive
Posted
Nov 09, 2017
Closes
Nov 20, 2017
Ref
1783479693
Contract Type
Full Time
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 is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

The Associate Director of Quality Systems, Quality Assurance reports to the WP Site Lead Quality System Associate Director. This position is critical to maintaining the clinical supply chain for investigational product. Specifically this position supports clinical investigations, clinical complaints, deviation management, change management records and CAPAs associated with these events. Areas of focus will be to undertake advanced tasks as it relates to complex / niche supply chains and supply types. Support is required from this role to manage significant Pharmaceutical Quality Council events related to clinical packaging such as formal Quarantine and Recovery actions that require rapid and effective liaison with many internal and external stakeholders at senior level. Additional support is required for direct responsibility for Global Clinical Supply IPT and process support.

Education:

+ Bachelor's Degree, Scientific or Engineering Discipline Major

Required:

+ Minimum of eight (8) years of experience in the Pharmaceutical industry or equivalent industry

+ Exceptional Leadership skills for the ability to lead teams of a cross-functional and multi-level nature, including senior management representatives

+ Excellent verbal and written communication and presentation skills

+ Computer skills; knowledge and competency in PowerPoint, Excel, and Word

+ Expertise in Change Management/Control and Deviation management

+ Ability to independently manage multiple priorities and projects

Preferred:

+ Strong knowledge of clinical development areas and processes within Merck

+ In depth working knowledge of Good Manufacturing Practices, including EU requirements

+ Comprehensive Lean Six Sigma and Project Management skills

+ Knowledge and competency in Trackwise

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.

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

**Job** _Clinical, Non Clinical Quality Assurance_

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

**Title:** _Associate Director, Quality Systems_

**Primary Location:** NA-US-PA-West Point

**Requisition ID:** _CLI006776_