Associate Director, Quality Assurance

Merck & Co.•Wilson, NC

51d•Hybrid

About The Position

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. Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Requirements

A Bachelor's degree, preferably in Science or Engineering
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

Nice To Haves

Thorough knowledge of plant wide systems/processes
At least two (2) years of supervisory experience

Responsibilities

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
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.