Job Description

Job Description

Provide compliance leadership and direction to Internal and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients (API), biologics, vaccine drug substances, and finished products. Support audits and health authority inspections and ensure any resulting corrective and preventative actions (CAPA) are effectively implemented.

Responsibilites include:

* Partner with Internal and CMO management to identify appropriate CAPA to address findings identified during audits and inspections. Monitor CAPA status and ensure CAPA are implemented in accordance with commitments. Perform independent verification of CAPA implementation and effectiveness to ensure no recurrence of finding

* Gather regulatory intelligence and partner with Internal and CMO management to prepare sites for audits and inspections. Assists sites during audits and inspections to ensure successful outcomes

* Serve as a subject matter expert for current good manufacturing practice (CGMP) requirements for pharmaceutical, biopharmaceutical, vaccine, or medical device industry

* Monitor and analyze the outcomes of audits and inspections to identify, investigate, and resolve trends. Report results to Divisional and Regional Quality/Management councils

* Author and/or review global standards and procedures related to biologics, vaccines, and finished product ensuring compliance with regulatory requirements

* Actively participate in industry organizations such as, PDA, PQRI, PhRMA, ISPE, etc.

Minimum Education and Experience Requirements:

* Education Minimum Requirement: B.S., M.S. and/or Ph.D. in life sciences, chemistry, engineering or related relevant discipline

* A minimum of 10 years of quality, operational or technical experience within the pharmaceutical, biopharmaceutical, vaccine, or medical device industry

* Expert knowledge of GMP requirements for multiple regulatory agencies

* Ability to accurately interpret and apply regulatory expectations for a robust and compliant QMS

* Experience in health authority inspections, a compliance decision-making role preferred

* Experience assessing remediation plans

Skills:

* Drive Results set clear performance standards, overcome obstacles; accountable for actions and achieve results

* Make Rapid, Disciplined Decisions demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions

* Act with Courage and Candor ability and willingness to advocate for compliance position using objective evidence, escalates issues and decisions, as appropriate

* Foster Collaboration ability to influence, facilitate groups with diverse perspectives, bring teams to consensus/alignment

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network thats devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

NewCo

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
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We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.

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Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

50%

Flexible Work Arrangements:

Not Specified

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R91594