Job Description

Join our Leadership Team as the US Regional Project Quality Lead! The Quality Lead builds and maintains strong relationships with the relevant cross functional teams for capital projects, supporting the coordination and alignment of individual Quality activities impacting Quality Operations. The Lead is responsible for the quality aspects of equipment and facility commissioning and qualification, and the supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations, employing Quality Risk Management principles.

The Lead will manage our Quality teams through end-to end support, from siting decision through Quality project team management, validation and regulatory approval as well as appropriate, post-execution evaluation.

Responsibilities:

• Acts as the QA/QC lead in establishing the quality assurance, quality control and compliance foundation in future project operations. Represents Quality within the project team and ensures guidance and support are provided in all aspects of the project’s future operations, including identification, design, development and implementation of the Quality and Compliance processes and systems.
• Provides coaching and upskilling to local cross functional team members on Quality and Compliance aspects of commissioning and qualification activities.
• Coordination, oversight and full support of all local qualification and validation activities.
• Point of contact for document preparation, and review, and/or questions regarding qualification activities.
• Supports preparation of training programs as required.
• Supports the strategy and design of qualification/validation methodologies, together with the project’s cross functional team.
• Ensures milestone delivery and prioritization of key phases of facility and equipment qualification and validation.
• Designs and implements appropriate measures to track adherence to established timelines, and project performance standards; ensuring realization of project goals through post-project execution follow-up mechanisms.

Location/Travel :

• The position is based at the DeSoto, KS site, and may require traveling to other AH sites, up to 25% of the time.

Minimum Qualifications:

• Bachelor’s degree in Chemistry, Pharmacy, Biology or Veterinary or related scientific discipline
• Minimum 7+ years’ experience in a leadership role within the Pharmaceutical Industry with Large Molecule/ biologics manufacturing, including site-based manufacturing or Quality
• Proven knowledge and understanding of USDA GMP regulations, guidelines and expectations in their application in daily operations.
• Broader understanding of complex (Animal Health) Quality Operations
• Proven analytical and problem-solving skills
• Strong communication and influencing abilities
• Proven ability to manage complex capital projects including commissioning, qualification and validation
• 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.
• A self-motivated, self-sufficient, inclusive leader

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US and Puerto Rico Residents Only:

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. 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 together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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, Monday - 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”.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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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:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

Yes

Hazardous Material(s):

n/a

Job Posting End Date:

05/24/2025

*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.