Associate Director, Clinical Supply Qms, Compendial Compliance (Hybrid)

Job Description

The Compliance and Quality Management Systems (CQMS) organization is part of the larger Global Development Quality (GDQ) organization within our company’s Research Laboratory Quality Assurance and is accountable for the execution of critical activities in the areas of compliance, quality systems, regulatory intelligence, and the Quality Management System (QMS).

The position reports to the Clinical Supply QMS Chapter 7 (Laboratory Controls) Continuum Owner in Global Development Quality playing a key role in establishing internal processes to support global compendial surveillance and working cross-functionally to support our company's review of compendial changes across the Clinical Supply organization. The position will utilize existing and evolving systems, assist in developing training and support continuous improvement opportunities related to Compendial Compliance.

The primary responsibilities of this position include, but are not limited to the following:

• Lead core compendial activities impacting our company, with a balanced focus on routine surveillance and Compendial Compliance initiatives to support the company’s business needs.  The position will be responsible for tracking new information and revisions published in the global pharmacopoeias and assessing the impact on our company.
• Serve as a subject matter expert, providing internal support for all compendial activities within Clinical Supply operations, and cross-divisionally with commercial operations as needed.
• Monitor the Pharmacopoeial Forum to proactively assess impact of proposed changes to Clinical Supply for our company.  
• Provide input and guidance to impacted stakeholders for applicable compendial requirements, to ensure ongoing compliance across our company.
• Support the development of strategic and tactical priorities related to compendial matters.
• Create training materials and implementation strategies for incorporating new policies and procedures and ensure adoption of all materials throughout our division.
• Provide support for above site and at site teams during regulatory inspections related to compendial and pharmacopoeia matters, as needed.
• Provide insight and contribute to Quality Management System (QMS) programs particularly as related to compendial matters.
• Identify and contribute to continuous improvement opportunities to support Chapter 7 (Laboratory Controls) of the QMS and other QMS Topics as assigned.
• Support the development, implementation and lifecycle management of an IT solution to manage compendial updates, assessments and implementation.
• Utilize and help promote process optimization efforts, application of best practices, and maintenance of tools/programs utilized to facilitate compendial processes.
• Participate in external forums to understand the current and future state of Compendial Compliance across the industry. Influence compendial changes when possible to best support the compliance and growth of the pharmaceutical industry.
• Support and/or lead other department priorities.

Education

• Degree in Life Sciences, Engineering or related relevant discipline.

• Required

  • Minimum of 8 years’ experience in the FDA and/or EU regulated pharmaceutical laboratory environment; preferably working with Pharmacopoeia in GMP setting.

  • In-depth knowledge of end-to-end compendial processes including interactions with global (e.g., USP and EP) and national (e.g.,ChP, JP, etc.) pharmacopeia is a desired.

  • Subject matter expertise in compendial changes (General Notices, Products, APIs, Excipients as well as general chapters).

  • Working knowledge of analytical techniques used in commercial testing of raw materials, excipients, and drug substance and drug products required, preferably with different product modalities (e.g., vaccines, biologics and pharmaceutical products).

  • Strong collaboration with internal teams to complete assessments and align on implementation strategies that best support the business and compliance posture of the organization are an essential skill for this role.

  Preferred

  • Experience working in cross functional teams.

  • Strong managerial skills including development and motivation of teams and experience working in Matrix / Cross Functional team environment is desired.

  • Familiarity with project management, establishing and reporting meaningful metrics is a plus.

  • Strong verbal and written communication skills as well as flexibility to work in a dynamic work environment.

  • Capable of communicating effectively with all levels of the organization globally and representing company positions externally in a professional manner.

  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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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, 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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

N/A

Requisition ID:R288368