Associate Director, SMDQ Rahway API Compliance Job

Rahway, NJ, US
March 20 2017
Organization Type
Associate Director, SMDQ Rahway API Compliance-CLI005758


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, SMDQ Rahway API Compliance reports to the Director, SMDQ Rahway API and supports development quality activities at the Rahway site or at other sites.

Primary responsibilities are:

The successful candidate will have leadership level accountability for GMP compliance, ensuring clinical supply functions operate within GMP requirements and compliant clinical drug substance supply. Drive compliance based programs and results which include leading cross functional projects, solving complex problems, cGMP quality initiatives, quality system improvements, quality alerts, internal audit program, compliance metrics and monitoring, SOP management, external inspections, site procedures.

Responsibilities include, but are not limited to:

1. Develop and implement strategic and efficient businesssolutions and effective quality processes.

2. Lead and collaborate in cross functional projects to develop effective processes or solutions. Apply critical decision making, project management skills to drive results.

3. Apply expert guidance and interpretation of Good Manufacturing Practice (GMP) and related regulatory requirements, standards, and guidance documents.

4. Investigate and resolve deviations and related non-conformances vs. GMP requirements and procedures.

5. Lead and conduct internal GMP quality audits or walkthroughs according to procedure against GMP requirements. Uphold quality standards and meet required timelines. Write clear, objective reports of audit findings and communicate them with audited areas. Approve and manage CAPA to closure.

6. Evaluate findings from Internal Audits and CAPA trends to identify and drive areas for improvement. Collaborate with operations partners on identification and implementation of appropriate solutions.

7. Organize and execute regulatory agency inspections, as needed.

8. 8. Manage and implement quality alerts, regulatory updates, and / or quality management system changes.

9. Author, review, and/or approve procedures (SOP) within Quality and for or with functional areas.

10. Proactively identify, develop, and implement work process improvements for efficiency and effectiveness.

11. Perform all other quality review or oversight tasks and projects as assigned or delegated.

12. Provide oversight of external partners. Perform regulatory inspection response and remediation on site or at external sites.

13. Conduct all work meeting high standards for quantity, integrity, quality, and GMP compliance.


Education Minimum Requirement:

- Bachelor degree in a Science or Engineering discipline (chemistry, biology, biochemistry, microbiology, engineering)

Required Experience and Skills:

- Minimum of twelve (12) years of experience in pharmaceutical, biotechnology, chemical, medical device, or a closely related industry.

- Experience in one or more functional areas such as quality control, quality assurance, laboratory, manufacturing, production, regulatory, research, development, supply chain, design, engineering.

- Good Manufacturing Practice (GMP) or related drug regulation knowledge and expertise.

- Strong leadership and communication skills.

- Ability to work in high impact, visible position to deliver results and make sound decisions.

- Ability to work across functions and sites, with all levels of staff and management.

- Ability to work in dynamic R&D environment with rapidly changing needs.

- Ability and willingness for periodic travel to external partners and contractors

Preferred Experience and Skills:

- Strong knowledge of drug R&D or clinical supply functions or work processes.

- Subject matter knowledge with drug substances or API.

- Track record for creating measurable results leveraging broad skills and experiences.

- Superior skills in collaboration, teamwork, conflict management.

- Advanced degree will be given preference.

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

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-NJ-Rahway

Employee Status: Regular

Number of Openings: 1

Shift (if applicable): 1st

Company Trade Name:Merck

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