Director of Quality Position Available In Durham, North Carolina

Job Description Our company is expanding its global recombinant vaccine production network by investing and adding a 225,000-square-foot building within the footprint of the Maurice R. Hilleman Center for Vaccine Manufacturing in Durham, NC. The new facility will be used to produce the bulk active ingredient for the vaccine, comprised of fermentation, microfiltration/ultrafiltration, purification and chromatography steps. The Director will be responsible for managing the Quality organization and overseeing the daily operations of the Operations Integrated Product Team (IPT). This role ensures that the production facilities and the operations conducted within them are maintained in compliance with Good Manufacturing Practices (GMP). Additionally, the Director will oversee the release activities associated with materials produced by the IPT. Job Functions Reports to the Executive Director of Quality and provides direction to Associate Directors, Managers, and professional staff. Contributes to departmental performance by adapting plans and priorities to meet operational challenges and aligning staff activities with objectives. Offers technical support and interprets client needs to identify effective solutions. Demonstrates strong written and verbal communication abilities, including preparing and delivering presentations to external stakeholders. Works independently and collaboratively within teams, fostering effective relationships across departments.

Management Responsibilities:

Plans and oversees departmental activities to achieve objectives. Manages performance and career development for supervisory and technical staff. Develops and implements operational policies and procedures. Reviews and approves lot disposition recommendations and deviation investigations. Administers budgets, schedules, and performance metrics, ensuring accountability for results. Participates in decision-making for capital expenditures and new technology acquisitions, while developing staffing plans and justifications. Utilizes continuous improvement methodologies to enhance departmental efficiency and maintain high-quality standards. Represents the department during FDA and other regulatory inspections, ensuring compliance and defending quality data. Identifies and resolves technical and operational issues, collaborating with peers across interrelated units. Recognizes that errors may lead to GMP compliance issues, regulatory deficiencies, and project delays, necessitating resource allocation for corrections. Makes informed decisions guided by policies and procedures, consulting with management on complex issues impacting interrelated processes. Adapts departmental plans based on operational challenges and division scorecards. Forecasts resource needs and manages the allocated budget effectively. Accountable for the performance of a small manufacturing sub-segment with plant transfers to inventory under $25M, typically managing Associate Directors and Managers Ability to sit, stand, and move within the workspace for extended periods, and perform repetitive tasks involving hand manipulations. Engages with employees at all levels, interacts with FDA inspectors and regulatory agencies, and collaborates with vendors, contractors, suppliers, and partners.

Minimum Education Requirements and Experience:

Bachelor’s degree in Engineering, Biology, Chemistry, Biochemistry or other relevant Life Science discipline with twelve (12) years’ experience supervising staff in a Quality Operations role and/or cGMP environment; OR Master’s degree in Engineering, Biology, Chemistry, Biochemistry or other relevant Life Science discipline with ten (10) years’ experience supervising staff in a Quality Operations role and/or cGMP environment; OR PhD in Engineering, Biology, Chemistry, Biochemistry or other relevant Life Science discipline with seven (7) years’ experience supervising staff in a Quality Operations role and/or cGMP environment Required skills and

Experience:

Experience supervising staff in a Quality Control and/or cGMP environment Familiarity with disciplines outside of primary areas of expertise 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”.

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:

Domestic VISA Sponsorship:

No Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable Shift:

1st –

Day Valid Driving License:

No Hazardous Material(s):

NA Job Posting End Date:

04/21/2025 •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. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.