Manager, Quality Control

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.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Quality Control (QC) Manager is accountable for oversight of activities performed in the QC laboratories to ensure timely release of high quality, compliant products to market.  The QC Manager is responsible for ensuring that the testing and results obtained in QC comply with internal and external regulatory guidelines.  Personnel tasks involve daily contact with the technicians under his/her direct supervision, including acting as a technical advisor and “coach”.  The QC Manager serves as a technical and administrative resource for other department personnel.  Additionally, the QC manager will utilize Lean/Six Sigma knowledge to make efficiency improvements in his/her department.

Position Responsibilities:

• Advocate “Safety First, Quality Always” mindset by perform periodic Gemba walks in the laboratory and in other departments. 

• The Quality Control Manager is accountable for managing the Quality Control and testing processes that support the facility, while actively supporting and participating in a team culture.  Coordinate laboratory activities with the technicians.  Ensure tests are performed within internal and external regulatory requirements and within established lead times. 

• Review testing results and data and be able to identify abnormal events for escalation. Coordinate the preparation of QC metrics reports needed for management meetings and discuss results at department or inter-department meetings.  

• Be actively involved in the hiring and training of technicians.  Act as a mentor/coach for the technicians directly reporting to this position.  Encourage development of direct reports to set and achieve objectives.  Write and perform the performance evaluations of direct reports. Handle interpersonal conflicts.              

• Provide leadership for the investigation of testing issues that may arise within QC.  Actively participate as needed and consult with other staff on related issues and special projects involving QC testing issues and methods.  Actively participate in the development and transfer of testing methods from Research & Development or other departments to QC. 

• Write and revise test methods, SOP’s, Outlines of Production, Special Outlines, test records, and forms and ensure that all documents used in QC comply with internal and external regulatory requirements.    Write and review technical reports for submission to USDA or other health authorities.

• Assist the QC management/Site Quality Head in the preparation of the annual budget.  Prepare documentation for budgeted capital equipment and supplies

• Participate in other special projects or activities as assigned by management.

Other duties may include

• Strategic Planning intended to develop and execute departmental plans and priorities based on site, regional or company driven goals.

• Support of regulatory inspections and audits.

• Support of validation activities and other associated Quality functions.

Education:

• Bachelors of Science degree in Microbiology, Biology, Biochemistry, Chemistry or a related field.

Required Qualifications and Skills:

• Knowledge of testing procedures and systems used in a QC laboratory.

• Knowledgeable in USDA testing procedures, supplemental assay methods and 9 CFR regulations. 

• Three to five years supervisory experience within the biologics industry.

• Experience with GMP documentation practices

• Individual must be highly organized and possess good planning skills to handle multiple projects.

• Individual must have good communication skills and ability to interface with all levels of the organization.

• Good technical writing experience

• Excellent computer skills (i.e. Word, Excel, Power Point, Microsoft Office, etc.)

Preferred Qualifications and Skills:

• Strong knowledge of USDA, GMP, FDA or EMEA regulation regarding vaccine manufacture

• Assay validation methods and report writing.

• Experience with lean, six sigma or similar

Required Skills:

Accountability, Accountability, Analytical Method Transfer, Analytical Testing, Analytical Thinking, Biochemistry, Biopharmaceutical Industry, cGMP Compliance, Corrective Action Management, Documentations, Driving Continuous Improvement, GMP Compliance, GMP Documentation, Immunochemistry, Instrumentation, Laboratory Operations, Lean Six Sigma (LSS), Mentorship, Microsoft Office, Microsoft PowerPoint, Multi-Management, Organizing, People Leadership, Pharmaceutical Quality Control (QC), Quality Control Management {+ 4 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

$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:

04/10/2026

*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.