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Merck & Co, Inc

Associate Director, Clinical Supplies Quality (Hybrid)

Science and Research

Clinical Research Director

No

West Point, Pennsylvania, United States

Job Description

The Associate Director, Clinical Supplies Quality, Global Development Quality is responsible for managing the West Point Clinical Supplies disposition activities in support of the clinical development programs for our company's portfolio, specifically in terms of assuring the reliable availability, quality and regulatory compliance of clinical supplies produced at West Point. This position reports to the Director, Clinical Supplies Quality and will have responsibility for operational management, capacity planning and scheduling for clinical finished goods and supporting activities as well as ensuring operational processes and systems are managed and enhanced.

Primary Activities:

This position will require an in-depth close collaboration with the key stakeholder groups as well as multiple Global Development Quality sites and functions that support the clinical supply chain. This position will also include navigating dynamic, high impact and high visibility situations on a regular basis in relation to ensuring that our company's clinical development portfolio/pipeline is not disrupted due to issues with clinical supplies. Dimensions of the role include operational management for clinical supplies disposition/issue resolution activities for over 300 active clinical protocols, supporting >10,000 clinical sites in approximately 70 countries. This position will also be responsible for managing direct reports.

In addition to the high-level responsibilities discussed above, the incumbent is expected to independently execute on the following:

  • Ensure reliability of clinical supplies availability for our company's clinical trials via daily operational management for the clinical finished goods disposition and supporting activities, with the associated potential for high impact to the development portfolio.

  • Assure capacity planning, scheduling and operational processes and systems are managed and enhanced for clinical supplies disposition and associated activities.

  • Support the development and execution of quality strategies, improvement initiatives in line with business drivers and objectives to ensure and enhance the robustness of our compliance posture whilst streamlining processes and procedures.

  • Provision of in-depth technical/quality expertise including identification of trends and/or potential compliance gaps and proactively leading the resolution of significant issues affecting quality in areas of expertise

  • Coaching, mentoring and developing team members supporting their personal development and also colleagues.

  • Assist, as part of the Clinical Supplies Quality Leadership Team, the development of strategic plans and translates and defines these in terms of related work processes and practices.

Skills:

Primary skills include but are not limited to:

  • Strong technical expertise in Research & Development (R&D) activities specifically related to clinical supplies, coupled with the ability to interact and influence stakeholder subject matter experts and senior leaders

  • Demonstrated operational management experience, including capacity planning and scheduling

  • Strong compliance knowledge and understanding of regulatory agency regulations and requirements including proficiency in interpreting and applying cGMPs to R&D environment

  • Demonstrated knowledge of continuous improvement methodologies; ability to manage complex cross-functional initiatives

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

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

Education & Experience:

  • Bachelor’s Degree in Scientific Discipline with 8+ years relevant experience within the pharmaceutical industry or advanced Degree with 6+ years relevant experience. A minimum of 2 years people management or leadership experience.

  • Experience interacting with regulatory officials and external auditing parties.

NOTICE FOR INTERNAL APPLICANTS

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 separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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 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:

EEOC Know Your Rights

EEOC GINA Supplement​

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, 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”.

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):


Requisition ID:R266382