MSD Associate Director Third Party Quality Management Drug Product Hybrid 

United States, New Jersey, Rahway 

338277973

Job Description

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

Key Responsibilities:

• Leading overall quality relationships with contract manufacturing organizations,

• Negotiation of site and global Technical and Quality Agreements,

• Participating in contractor GMP audits as a Subject Matter Expert,

• 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,

• Supporting product development teams in outsourcing activities to enable our diverse pipeline

• Serving as the bridge for quality oversight between research and development and commercialization activities.

• Communicating, and serving as Quality spokesperson, on a variety of Quality or compliance-related issues.

:

• Minimum of 5 years within pharmaceutical drug product manufacturing and 10 years overall within biopharmaceuticals.

• Planning and facilitating high risk and highly complex Quality-related process reviews and/or investigations under minimal supervision.

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

• Identifying trends and/or potential compliance gaps and proactively leading the resolution of issues affecting quality and efficiency.

• Interpreting complex regulatory requirements for various audiences, including source area management, and facilitating communication of these requirements across stakeholders.

Preferred Experience:

• Experience related to medical devices and combination products,

• Engagement with small and/or large molecule drug development programs from early phase through commercialization

• Participation with contract manufacturing of clinical supplies

Education Minimum Requirement:

• Bachelor's degree in relevant area related to engineering, chemistry, or biology.

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.

Current Contingent Workers apply

US and Puerto Rico Residents Only:

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:

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 aagreement (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”.

Expected salary range:

$122,800.00 - $193,300.00

1st - Day

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

08/05/2024

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.