Associate Director, Third Party Quality Management Drug Product (Hybrid)

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 Drug Product. Additionally, experience in medical device and/or combination products would be preferred. Key activities that 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 Vendor 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.

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 incumbents would be the key quality representatives attending and contributing at oversight and business review meetings with our Company and contractor personnel to discuss projects, financial, operational/quality and overall performance topics.

In addition to the job specific responsibilities discussed above, the incumbents are 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 of a Bachelor's degree in relevant area.

Experience:

• Minimum of 5 years within pharmaceutical Drug Product manufacturing and 10 years overall within biopharmaceuticals.

NOTICEFORINTERNALAPPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

GRACSJOBS

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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US and Puerto Rico Residents Only:

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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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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.

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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, generally Tuesday, Wednesday and either Monday or 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".

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:

$122,800.00 - $193,300.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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:

25%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Requisition ID:R292703

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