Manager, Quality Systems & Compliance

Job Description

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way.

Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do.

At our company's Animal Health division, we are dedicated to advancing the prevention and treatment of diseases in animals through innovative health solutions. We are seeking a highly skilled and motivated Quality Assurance Manager to join our team. This role is crucial in ensuring the highest standards of quality and compliance in our manufacturing processes. If you are passionate about quality assurance and have a strong background in quality systems, risk assessments and compliance we invite you to apply and contribute to our mission of saving and improving lives around the world.

Our Quality Assurance team ensures every single material inside of our products is manufactured, processed, tested, packaged, stored and distributed aligned with our high standards of quality and meets all regulatory requirements.

We are seeking a growth and improvement minded individual to join our Quality Assurance (QA) team as the Manager, Quality Systems & Compliance that can help drive our Strategic Priorities. This role will manage between 6-9 direct reports and will report to the Associate Director of Quality Assurance.

Responsibilities:

• Leadership, feedback, and coaching to QA colleagues through routine performance evaluations and responsibility oversight activities

• Compliance oversight and guidance for Manufacturing Integrated Processing Teams (IPT's), Engineering/Maintenance and other production adjacent departments

• Actively contribute to manufacturing teams by providing guidance and oversight in relation to the 9 CFR and company Quality Standards

• Participate in manufacturing walks and internal/external audits

• Oversee disposition of raw materials, in-process antigens and finished vaccines

• Quality System oversight including Deviations, CAPAs, and Change Controls

• Drives continuous improvement of all quality systems and compliance activities

• Assist with or communicate directly through verbal and/or in writing with regulatory authorities

• Participate in and provide direct guidance during external audits and inspections

• Help manage and maintain adherence to the QA budget

• Communicate product quality problems and provides metrics for Tier meetings, Site Quality Council, and Extended Leadership Team meetings

Education Requirements:

• Bachelor's degree (science or engineering degree preferred)

Required Experience / Knowledge / Skills:

• Five (5) years in a Quality or Manufacturing role in a government regulated industry

• Able to work independently and as a team member with integrity, precision, and respect

• Principled verbal and written communication

• Lead and work within a team

• Consistent decision-making abilities

• Root Cause Analysis and Troubleshooting skills

• Technical writing skills

Preferred Experience / Knowledge / Skills

• Working knowledge of good aseptic techniques

• Knowledge and familiarity with the 9 CFR and the USDA

• Experience in Lean, Six-Sigma or Operational Excellence

Required Skills:

Accountability, Accountability, Applied Engineering, Audits Compliance, Compliance Reviews, Consulting, Corrective Action Management, Driving Continuous Improvement, IS Audit, Manufacturing Processes, Manufacturing Support, Production Supervision, Professional Integrity, Quality Assurance (QA), Quality Control Management, Quality Improvement Programs, Quality Management, Quality Management Systems (QMS), Quality Process Development, Quality Standards, Regulatory Compliance Consulting, Reporting and Analysis, Risk Management, Root Cause Analysis (RCA), Supplier Quality Management {+ 3 more}

Preferred Skills:

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

$96,200.00 - $151,400.00

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 https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (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):

n/a

Job Posting End Date:

03/9/2026

• 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:R385645