Job Description

The incumbent will be responsible for serving as the quality representative for, and providing quality oversight of, contractors performing various GMP activities supporting the production of clinical supplies with focus on analytical testing. Key activities this position would be responsible for include: leading internal contractor related issue investigation and resolution teams, review and approval of contractor-initiated investigations associated with deviations, negotiation of site and global Technical and Quality Agreements, maintenance and accuracy of the Development Approved Supplier Listing, participating in contractor GMP audits as a Subject Matter Expert, development and creation of contractor related metrics, conduct of contractor "deep dive" quality assessments such in data integrity and leading cross-functional contractor performance reviews as the quality lead for the oversight platform. Experience in medical device and/or combination products testing would be preferred.

The position will be heavily involved in close collaboration with the contractor quality and technical personnel and interacting with their functional equivalents in Quality Disposition and Pharmaceutical Research and Development and, Procurement on strategic objectives utilizing external contractors including GMP qualification as well as site/project selection. Additionally, the incumbent would serve as the bridge between R&D and Commercialization activities and develop a strong working relationship with commercial external quality management personnel.The incumbent would be the key quality representative attending and contributing at oversight and business review meetings with our Company and contractor personnel to discuss projects, operational/quality and overall performance topics.

In addition to the job specific responsibilities discussed above, the incumbent is expected to independently execute on the following:

• Plans and facilitates high risk and highly complex Quality-related process reviews and/or investigations under minimal supervision

• Provides project leadership in area of expertise in own discipline (such as leading or facilitating teams involving source area representatives in a matrix management environment)

• Leads Quality-related reviews, cross-functional process teams and/ or investigations, serving as a subject matter expert

• Engages in strategic planning activities across the Quality Unit and directly responsible for project planning and activities of self and indirect reports associated with team activities

• Makes independent decisions and acts with authority to carry out required actions

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

• Lead the resolution of business practice, Quality and/ or compliance issues of broad scope and highest level of complexity on cross-functional and/ or cross-divisional basis

• Identifies trends and/or potential compliance gaps and proactively leads the resolution of long-standing or significant issues affecting quality and efficiency

• Leads communication, and serves as Quality spokesperson, on a variety of Quality or compliance-related issues

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

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

• Identifies and leads implementation of Contractor and Supplier System improvements

Education Minimum Requirement:

• Bachelor Degree in Chemistry, Biology, Engineering or related field

Required Experience and Skills:

• At a minimum the position requires a Bachelor's Degree with 8+ years of relevant experience within the pharmaceutical industry. Advanced Degree with 5+ years relevant experience.

• Strong scientific/ technical expertise in R&D activities, coupled with the ability to interact with scientific subject matter experts on various product initiatives and issues relating to Analytical Testing.

• Flexibility to travel up to 15% both domestic and international.

Preferred Experience and Skills:

• Experience in medical device and/or combination products testing would be preferred.

• Strong compliance knowledge of GMP regulations coupled with proficiency in interpreting and applying GMPs to a R&D environment

• Strong understanding of regulatory agency regulations and requirements

• Experience in Biologics and/or Vaccine method development, characterization, technology transfer, and release

• Strong scientific/ technical expertise, perspective and judgment in the selected subject matter area coupled with the ability to interact with scientific subject matter experts on various product initiatives

• Ability to independently interact with regulatory officials and external auditing parties

• Possess deep drug development knowledge; demonstrated ability to facilitate training and learning in colleagues and apply knowledge to enhance the drug development process

• Demonstrated knowledge of continuous improvement methodologies; ability to lead matrix teams, recognize improvement opportunities, develop appropriate solutions and follow through on implementation

• Strategic view of project issues in a Quality Systems environment

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

• Demonstrated skills in communicating (oral and written) effectively with diverse individuals/ groups

• Demonstrated time management skills, ability to conduct well defined projects within discipline or area of expertise

• Demonstrated skills in leading; operational planning (3 months to 1 year span); integrating, managing, and/or coordinating similar/ related teams, units, work processes or functions

#EligibleforERP

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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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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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Job Posting End Date:

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Requisition ID:R322776