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Associate Director, Quality Assurance Job

Employer
Merck
Location
West Point PA
Closing date
Mar 29, 2017

Job Details

Associate Director, Quality Assurance-CLI005737

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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


The Associate Director is responsible for the management, execution and leadership of quality activities to ensure compliance with cGMPs, applicable worldwide regulations, and Merck requirements for supported area(s). The Associate Director is also responsible for providing assessments to senior management as to the compliance status and risk posture of supported area(s), Due Diligence programs, and guidance on alignment of policies and procedures with current regulatory expectations. Additional responsibilities include supporting the development of capacity planning and annual Profit Plans, and ensuring department financial goals are met. The Associate Director may also operationally supervise Development Quality staff, contingent employees, or loan labor.

- Remain informed of current GMP requirements and industry trends as described in applicable worldwide regulations and industry standards. Provide comments on proposed regulations and communicate impacts to client areas. Maintain an expert level of knowledge related to specialized area of technical expertise.

- Ensure departmental SOPs reflect departmental procedures and the current regulations. Responsible for oversight of SOPs in supported areas and ensure periodic updates, as appropriate.

- Manage the audit and/or approval of GMP documentation for applicable regulatory filings, clinical supply, development and technology transfer, facility and/or equipment qualification. Ensure compliance with regulatory and Merck requirements. Evaluate deficiencies and assess impact on compliance status.

- Coordinate preparations for regulatory agency inspections, as applicable. Accompany regulatory agency officials conducting inspections of facilities or operations in supported areas, including GMP Certification inspections and issue formal reports of inspection activities. Facilitate inspections by corporate auditors or external, non-government auditors in supported areas. Coordinate the drafting of responses to inspectional observations to satisfy Merck and/or regulatory agency requirements.

- Advise supported areas on the GMP compliance aspects of the design of facilities, selection of equipment (including computerized systems), preparation of departmental SOPs, quality practices, policies, and interpretation of applicable worldwide regulations.

- Act as Quality representative for in-house or outsourced manufacturing programs. Duties include compliance oversite of program-related activities, batch record review and approval, deviation and/or out-of-specification approval, etc.

- Support of Due Diligence/outsourced programs including travel to other countries (e.g., EU). Travel may be 5% depending upon program needs.

- Efficiently manage all activities within resource constraints while complying with all Merck policies and regulatory requirements.

- Develop/approve quality system and/or policy for Development Quality department as needed.

- Represent the department or area on project teams or committees establishing GMP, or quality standards, policies or expectations within Merck.

- Manage GMP audit/inspection program for facilities, systems (including computerized systems) and operations at contractors or licensees, engaged in the processing, testing, or holding of clinical supplies. Evaluate deficiencies and assess impact on compliance status. Issue reports summarizing deficiencies and work with departments to resolve such deficiencies. Notify appropriate Quality and support area management of compliance issues and performance trends.

- Specific and/or additional duties may include, but are not restricted to:

- Assess the suitability of GMP data and material potentially available for use in clinical trials through the establishment of license­ agreements and advise Senior Staff on recommendations. Work with licensee on the identification of information required for Merck reviews of such programs.

- • Manage the clinical release or re-evaluation dating to ensure conformance to appropriate worldwide regulatory requirements.

Qualifications

Education Minimum Requirement:

- B.S., M.S. and/or PhD. degree in an appropriate Science or Engineering discipline. Minimum of 8-10 years experience with B.S./M.S., or five (5) years with PhD.

Required Experience and Skills:

- Pharmaceutical/biotechnology industry with five (5) years in a technical, quality, or compliance role.

- Direct or indirect management experience.

- Extensive working knowledge of cGMPs and technical aspects of support area are required.

- Effective communication, negotiation, problem-solving, and interpersonal skills with demonstrated project management abilities are necessary to perform job responsibilities.

Preferred Experience and Skills:

- Previous experience required to perform job responsibilities may include: quality assurance, auditing, or regulatory submission requirements.

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. 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:

EEOC Poster

EEOC GINA Supplement​



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


Job: Clinical, Non Clinical Quality Assurance

Job Title:Assoc. Dir, Quality Assurance

Primary Location: NA-US-PA-West Point

Employee Status: Regular

Travel: Yes, 5 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Company Trade Name:Merck

Company

Our vision is to make a difference in the lives of people globally through our innovative medicines, vaccines, biologic therapies, consumer health and animal products. We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.

We have made it our mission to provide innovative, distinctive products and services that save and improve lives, satisfy customer needs and to be recognized as a great place to work

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