Job Description

Description:

Reporting to the AVP of New Modalities our company's Manufacturing Division Quality, this leader is responsible for supporting the implementation of a unique quality oversight model necessary to facilitate agility and speed-to-market while ensuring sustained compliant supply of specialty New Modalities pipeline products to global markets, to serve our patients. This leader will support the implementation, including change management actions, of the organization to support a fit-for-purpose quality management system and ensure strategic quality oversight of new modalities products manufactured in our company's network and at external partner sites. The leader will interact with our company cross-divisional/functional teams from development through commercialization to ensure implementation of the designed quality oversight model. Activities will include implementation of required Quality Management System (QMS) elements, procedures, and systems to ensure quality and regulatory compliance with Current Good Manufacturing Practices (CGMPs), other worldwide regulations and our company's requirements.

Primary Responsibilities:

• Provide personalized therapy subject matter expertise to the New Modalities Quality team.

• Provide Quality leadership as part of the new Quality Platform to ensure end to end quality oversight necessary to facilitate agility and speed-to-market while sustaining compliant supply of New Modalities pipeline products to global markets.

• Evaluate current our company's and partner Quality Management Systems for seamless integration and realize synergies where available while ensuring compliance to GMP requirements. Ensure alignment to corporate policies as well as other divisional policies related to management of product quality.

• Implement a fit-for-purpose QMS, ensuring end-to end quality oversight of New Modalities products manufactured at our company and external partner sites. Partner with our company's Manufacturing Division QMS team for QMS updates as needed.

• Support establishment of New Modalities Global Quality Management processes and Regulatory Compliance plan in support of early-stage development to commercialization of New Modalities products.

• Work in partnership across our company's organization to understand the unique requirements for the new modality products and ensure that these requirements are addressed via fit-for-purpose quality management oversight.

• Evaluate external partner Quality and compliance robustness and identify Quality risks. Work with internal from our company's colleagues and external partners to remediate risks as appropriate. Ensure that facilities/processes are compliant and support approval of new modality regulatory filings.

• Maintain close working relationship with our company/ our Manufacturing Division Quality departments and our company/our Manufacturing Division Technical CMC teams for end-to-end Quality oversight/support of New Modalities products.

• Support development of and report quality metrics measuring operational effectiveness to appropriate our company /our Manufacturing Division governance forums.

• Ensure continuous improvement to New Modalities QMS to maintain GMP and Regulatory compliance.

• Stay ahead of current GMP requirements and industry trends as described in worldwide regulations and industry standards, and trend reporting. Maintain a subject matter expert level of knowledge related to these specialized areas of expertise, with a specific focus on personalized therapies.

• Provide guidance and coaching to our Manufacturing Division colleagues on New Modalities quality oversight requirements and Health Authority GMP expectations.

Required:

• Bachelor's degree in Life Science Field, Engineering field or a related relevant discipline.

• Minimum of ten (10) years' experience within the pharmaceutical industry.

• Direct experience in manufacture of or quality/technical support to manufacture of personalized medicines / cell gene therapy products or similar

Required Leadership and Technical Skills:

• People change management experience

• Technical experience with vaccines, biologics, and / or cell gene therapy products

• Technical Operations, Quality operations and/or compliance experience

• Demonstrated effective leadership, communication, interpersonal and negotiating skills, in particular with cross functional partners

• Ability to learn and understand technical aspects of new processes to ensure robust Quality oversight

Preferred:

• Experience in both Quality Assurance and Quality Control

• Experience in external manufacturing / external quality assurance or alliance management

• Experienced in interacting with regulators

• Advanced degree in Life Sciences field, Engineering field or a related relevant discipline

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, 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".

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Requisition ID:R321302