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US Regional Project Quality Lead

3 months ago

Southaven, Mississippi, United States Merck Full time

Job Description

Position Overview - Basic Functions & Responsibilities (including, but not limited to):

  • Acts as the QA/QC lead in establishing the quality assurance, quality control and compliance foundation in future project operations. The incumbent represents Quality within the Project Team and ensures guidance and supports provided on all aspects of the project's future operations, including identification, design, development and implementation of the Quality and Compliance processes and systems.
  • Designs, and implements appropriate measures to track adherence to established timelines, and project performance standards; The incumbent is responsible for ensuring realization of project goals through post-project execution follow-up mechanisms.
  • As a member of the Transfer Quality Team, the incumbent provides Quality strategy guidance and direction, oversight and support to all transfer activities involving the transfers of large molecules from, into, and within the production sites. This includes E2E support, from siting decision through Quality project team management, validation and regulatory approval as well as appropriate, post-execution evaluation.
  • With respect to Transfer Quality Compliance Support, the position ensures appropriate support acting as the point of contact for any quality topic including but not limiting:
    • Applying AHQM/Quality Standards guidance for US Region transfer projects
    • Applying and communicating/sharing preferred transfer practices
  • With respect to Transfer Quality Operational Site Support, the incumbent ensures communication and overview of the progress of the Local Quality activities related to transfers, including, among others:
    • Coordination and full support of all local Quality transfer activities.
    • Acting as point of contact for document preparation, and review, and/or questions regarding quality transfer activities.
    • Supports preparation of training programs as required.
    • Provides oversight to the progress of ALL local Quality (QC/QA) transfer activities.
    • Supports the design, and creation of transfer documents, together with transfer's cross functional team.
    • Manages assigned process & Quality site transfer projects in alignment with site's Quality teams and other functions
    • Ensures milestone delivery and prioritization of complex transfer Quality projects, including for Quality Assurance document review, and release processes, Quality Control methods, and stability studies, as required.
    • Ensures milestone delivery and prioritization of process transfer projects connected to site's manufacturing activities.
    • Links closely with Task Force Teams through Global Quality Transfer leadership.
  • To be successful, the incumbent has to build and maintain strong relationships with the relevant cross functional teams for transfer, supporting the coordination and aligning individual Quality activities impacting Quality Operations.
  • Provides coaching, and upskilling to local cross functional team members on Quality and Compliance aspects of transfers.
  • To fulfill the role/position, the incumbent:
    • partners closely with Donor or Receiving cross functional teams (across network, and/or within site) to ensure progress of all Quality transfers.
    • partners closely with local quality teams to align on activities and due dates.
    • partners with other global support functions such as Global LMQ Transfer team, Global Supply chain, BTS, R&D, APS, and others as appropriate
    • Supports and ensures collaboration and exchange of preferred cGMP practices across the network.

Location/Travel

  • The position is based at the DeSoto, KS site, and may require traveling to other AH sites, up to 30% of the time.

Skills, Education and Experience

  • Bachelor's Degree in Chemistry, Pharmacy, Biology or Veterinary or related scientific discipline
  • Minimum 7+ years experience in Pharmaceutical Industry with Biological products, including site-based manufacturing or Quality, in a leadership role
  • Proven knowledge and understanding of USDA GMP regulations, guidelines and expectations in their application in daily operations.
  • Proven analytical and problem-solving skills
  • Strong communication and influencing abilities
  • Proven ability to manage complex projects
  • Strong ability to initiate and drive change within complex organizations
  • Learning ability: autodidactive, actively learning new concepts, applying in practice and training others
  • Task-oriented leadership connects to strategy, leads complex multidisciplinary (global) projects and programs and has the ability to drive project sponsorship and gain support and resources.
  • Relationship building to peers (including global functions) and senior management.
  • Focus on results: drives results based on strategy and customer needs.
  • Self-reflection: is actively looking for feedback and translates this to personal development actions.
  • Results-oriented
  • Broader understanding of complex (Animal Health) Quality Operations
  • A self-motivated, self-sufficient, inclusive leader

#EBRG

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 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.

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:

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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".

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

Yes

Hazardous Material(s):

n/a

Job Posting End Date:

05/29/2024

*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.

Job Posting End Date:05/29/2024

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.

Requisition ID:R294382