Job Description

The Authorized Person (AP), Associate Director, Clinical Supplies Quality, plays a critical role in the review and certification of batches intended for use in clinical trials. The AP will be involved with Health Authority Inspections, audits both internal and external, as well as ongoing compliance activities related to clinical trials, technical and quality agreements with collaborators, stock recovery activities etc.

This dynamic position will have responsibility for support of US quality operations and disposition, global distribution planning and management, and requires organizational skills and leadership to work effectively and proactively on global functional teams.

Primary Responsibilities:

• Responsible for disposition and support of Clinical Supply Chain for clinical development programs for our Company's portfolio, specifically in terms of assuring the reliable availability, quality and regulatory compliance of clinical supplies produced

• Development and execution of Quality and key stakeholder strategies, improvement initiatives in line with business drivers and objectives whilst streamlining processes and procedures and leveraging technology.

• Closely collaborate with appropriate business/operations areas to ensure that effective and robust Quality systems and processes are in place.

• Ensuring the reliability of clinical supplies availability for our Company's clinical trials via development of business processes, tools, and data analytics, with the associated potential for high impact to the development portfolio.

• Provision of in-depth technical / quality expertise regarding interpretation of data, development of metrics, identification of trends and/or potential compliance gaps and proactively leading the resolution.

• Global Stewardship for process development and improvement, providing expertise and guidance, and ensuring consistent application of functionality for the Quality teams supporting the end-to-end Clinical Supply Chain.

• Process ownership, development and management of high profile and high impact significant quality events related to clinical supplies including fact-finding, investigation, coordination of clinical quarantine and recovery actions involving cross-functional interactions with diverse groups at senior levels.

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

Education Minimum Requirements:

• Bachelor’s degree in engineering, Biology, Chemistry, or related field.

• A minimum of 5+ years of relevant experience working within the pharmaceutical industry.

Preferred Experience and Skills:

• Experienced and strong people manager with proven track record of developing talent

• Strong comprehension of regulatory agency regulations and requirements coupled with proficiency in interpreting and applying current Good Manufacturing Practices (cGMPs) to our Research & Development environment.

• Strong technical expertise in our Research & Development activities specifically related to clinical supplies, Medical Device/Combination Products, design, and implementation of new technologies etc.

• Demonstrated operational management experience, including capacity planning, forecasting, and scheduling.

• Demonstrated knowledge of continuous improvement and project management methodologies; ability to lead matrix teams and direct complex cross-functional initiatives, recognize improvement opportunities, develop appropriate solutions, and follow through on implementation.

• Demonstrated leadership, including strategy development / deployment and experience with tangible delivered benefits.

• Demonstrated experience in quality risk management in the pharmaceutical industry.

• Strongly developed cross-functional teamwork, collaboration, influencing and negotiation skills.

• Demonstrated excellence of skill in communicating (oral and written) effectively with diverse individuals/ groups at all levels.

• Computer skills; knowledge and competency in SAP, ERP/MES, Trackwise, PowerPoint, Excel, and Word.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

No

Job Posting End Date:

03/19/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.