Director, Quality Assurance New Modalities, Antibody Drug Conjugate

Job Description

Reporting to the AVP of New Modalities Manufacturing Division Quality, this leader is responsible for providing Antibody Drug Conjugate (ADC) expertise and supporting a 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 leverage ADC experience to support the implementation of 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's cross-divisional/functional teams from development through commercialization to ensure implementation of new quality guidance and 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 Quality leadership as part of the New Modalities Quality team 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.-
• 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 Antibody Drug Conjugates.-
• Provide guidance and coaching to manufacturing colleagues on new modalities quality oversight requirements and Health Authority GMP expectations.
• Evaluate current company 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.
• Work in partnership across the organization (Research, Manufacturing and Commercial) 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 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 research and manufacturing divisions' Quality departments and 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 research and manufacturing divisions' governance forums.
• Ensure continuous improvement to new modalities QMS to maintain GMP and Regulatory compliance.

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.-
• Experience working with or directly supporting manufacture of Antibody Drug Conjugate (ADC) products.

Leadership and Technical Skills:

• People change management experience
• 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:

• Technical experience with vaccines, biologics, and / or cell gene therapy products
• Experience in both Quality Assurance and Quality control
• Experienced in interacting with regulators.
• Advanced degree in Life Sciences field, Engineering field or a related relevant discipline.

EligibleforERP

Required Skills:
Animal Vaccination, Animal Vaccination, Antibody Therapeutics, Applied Engineering, Cell Physiology, Change Agility, Change Management, Coaching, Cytopathology, Data Integrity, Decision Making, Gene Therapy, Global Health, GMP Compliance, Interpersonal Relationships, IS Audit, Leadership, Leadership Training and Development, Manufacturing Quality Control, Operational Efficiency, People Leadership, Pharmaceutical Biology, Pharmaceutical Management, Quality Auditing, Quality Management Standards {+ 5 more}

Preferred Skills:

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.

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:

EEOC Know Your Rights

EEOC GINA Supplement•

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.

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, 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 salary range for this role is
$173,200.00 - $272,600.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
No

Job Posting End Date:
02/25/2026
*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: R383004