Associate Director, Quality Assurance - Hybrid

Job Description

Working in the Finished Goods Platform, TPQM (Third Party Quality Management) within our Research & Development Division, the position will be responsible for serving as the key representative for the quality oversight of Clinical Finished Goods Contractors. The role will also lead GMP/GDP activities supporting the production of clinical supplies, on behalf of our Company.

Key responsibilities include:

• Managing the quality oversight of Third-Party Vendors for Clinical Finished Goods (FG).

• This dynamic position would also play a role in the review and certification of batches intended for use in clinical trials. Play a role in supporting Health Authority Inspections, participating in audits both internal and external by acting as a Subject Matter Expert as well as ongoing compliance activities related to clinical trials, technical and quality agreements.

• Lead and manage high profile and impact significant quality events related to clinical supplies (both internal and CMO) including fact-finding, investigation, coordination of clinical quarantine and recovery actions involving cross-functional interactions with diverse groups at senior levels.

• Review and approval of contractor-initiated investigations, negotiation of Quality Agreements, development and creation of contractor related metrics and conduct of “deep dive” quality assessments such as in data integrity.

• Lead cross-functional contractor quality performance reviews.

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

The position will be heavily involved in close collaboration with external contractor quality and technical personnel. Internally interacting closely with Quality Disposition, Pharmaceutical Research/Development and Procurement on strategic objectives-utilizing external contractors including GMP qualification as well as site/project selection.

Additionally, you would lead on projects related to quality oversight of vendors such as helping to develop key quality performance metrics. Serving as the bridge between R&D and Commercialization activities developing strong working relationships with commercial external quality management personnel. Acting as the Leading quality representatives attending and contributing at quality oversight and business review meetings with internal and External Stakeholders to related to CMO performance.

In addition to the job specific responsibilities discussed above, you would be expected to independently execute the following:

• Leading projects in a matrix management environment.

• Engages in strategic planning across the Quality Unit.

• Makes independent decisions and acts with authority to conduct required actions.

• Identifies and leads implementation of Clinical Finished Goods System improvements.

• Leads others in a matrix/management environment and coaches, mentors, and develops colleagues in areas of expertise. 

• 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.

• Interprets complex regulatory requirements for various audiences, including source area management, and facilitates communication of these requirements across stakeholders. Reviews draft policy, procedures, and standards.

• Communicates with senior management within our company and the contractor organization. Facilitates and/or prepares cross-functional management presentations.

• Demonstrated leadership, time management skills, effectively prioritize, and manage conflicting priorities.

Education:

• Bachelor’s Degree in: Pharmacy, Biology, Engineering, Chemistry, or related field

Required Experience and Skills:

• At a minimum, this position requires a bachelor’s degree with a minimum of ten (10) years of relevant experience within the pharmaceutical industry or Advanced Degree with a minimum of eight (8) years relevant experience.

• Strong scientific/ technical knowledge and experience in R&D activities, coupled with the ability to interact with scientific subject matter experts on various product initiatives and issues in the following areas:

  • Clinical Packaging and Labelling,

  • Distribution of clinical supplies.

  • Knowledge/ experience of Regulations and Regulatory Health Requirements for dispositioning of Clinical Finished Goods

  • Experience in Quality Management of CMOs.

Preferred Skills and Experience:

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

• Excellent communication skills (oral and written) effectively with diverse colleagues/ groups.

• 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 innovative technologies etc.

• 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.

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

• Experience in quality disposition and or final batch release.

• Demonstrated Strategic Project Development and time management skills, ability to conduct well defined projects within discipline or area of expertise.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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  

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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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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. 

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