Associate Director, Quality Assurance

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Under the general supervision of the Executive Director, Quality Operations, the Associate Director is responsible for Quality Assurance including, but not limited to:

• Change control

• Batch record review and release

• Packaging and vendor investigations

• Component and bulk release

• Defect resolution

• Retention

• SAP master data

• Site wide internal and external audits

• Regulatory document reviews

• Product complaint management

• New product introductions and other Quality Assurance related functions.

The Associate Director, Quality Assurance will oversee a staff of approximately 5 – 15 employees, which typically consists of Associate Specialists, Specialists, and Senior Specialists responsible for Quality Assurance.

Primary activities may include, but are not limited to, the following: Responsible for quality assurance functions for plant-wide systems/processes to include direct line support to production areas, batch record review and release, bulk and component review and release, retention, investigations and defect resolution. Ensures that Quality Operations responsibilities for audits, regulatory document reviews, SOPs, PCRs and other Quality Assurance related systems are properly implemented, conducted, and documented.

Responsible for the control and ultimate disposition for the final release of finished goods from the site. Provides final approval of packaging investigations. Provides release decisions at the Wilson site for materials designated for other than domestic distribution and facilitates appropriate communication thereof. Approves and maintains appropriate delegation of release decisions as required. Interviews and hires personnel, ensures proper training of personnel is completed, and recommends salary actions for employees being managed within the framework of company policy.

Education Minimum Requirement:

• Bachelor's degree, preferably in Science or Engineering

Required Experience and Skills:

• A minimum of six (6) years of pharmaceutical industry experience, preferably in Quality

• The ability to provide technical direction and training to include Good Manufacturing Practice, safety practices, and documentation practices as they relate to the quality assurance of the product.

• Expertise in the Quality Assurance discipline and the ability to apply knowledge of internal/external challenges to improve products and processes.

• A demonstrated understanding of customer needs, requirements and expectations

• Experience assisting in the direction of plant wide or department objectives

• Strong organizational and time management skills.

• The ability to work independently with minimal guidance

Preferred Experience and Skills:

• Thorough knowledge of plant wide systems/processes

• At least two (2) years of supervisory experience

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:

EEOC Know Your Rights

EEOC GINA Supplement

Pay Transparency Nondiscrimination

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.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

• 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:R338769