Associate Director, Quality

Job Description

Job Description

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 expectations. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Under the general supervision of the Quality Director, the Associate Director of Quality is responsible for quality assurance activities including, but not limited to, batch record review and batch disposition, deviation investigations, document control, internal and external audits/inspections, regulatory document reviews, change control, Quality Risk Management, and other compliance-related projects. Potential to manage a staff of 2-4 salaried employees.

Primary Activities

• Responsible for quality assurance functions for plant-wide systems/processes to support production areas, batch record review and batch disposition, and deviation investigations. Ensures the proper execution and life cycle management of audits, regulatory document reviews, SOPs, Change Requests, Quality Risk Management, Annual Product Reviews and other compliance-related systems.
• Responsible for the control and disposition of Active Pharmaceutical Ingredients and intermediates. Sets compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory expectations. Proactively evaluates site compliance against emerging regulatory trends. Independently facilitates initiatives to improve compliance status and overall operational efficiency of the site. Actively participates in Plant/Quality committees and works with other site functional groups, such as the QO Laboratory, Production, Technical Operations, Utilities and Maintenance to set direction for plant-wide GMP initiatives.
• Manages the operation in accordance with company policy and applicable government regulations and is thoroughly knowledgeable concerning Quality Assurance activities. Makes provisions to assure job responsibilities of the Quality Assurance area are conducted in a timely and reliable manner to meet production demands. Ensures compliance with all cGMP, environmental, health and safety guidelines and procedures, and notification of any adverse events.
• Performs the duties and responsibilities of the Quality Director and other Associate Directors of Quality Systems and Compliance associated with the above in their absence. Acts as a key regulatory compliance liaison to interface with regulatory agencies during audits.
• Conduct audits of the facility, our Manufacturing Division sites, and external suppliers. Handles routine matters independently, consulting the Director on major issues only.
• Ensures that Quality Assurance maintains the necessary human and capital resources to meet present and future needs of Operations and manages those resources to meet annual profit plan. Interviews and hires personnel, ensures proper training of personnel is completed, and recommends salary actions for employees being managed within the framework of our Company policy.
• This job requires a substantial amount of working with Beta Lactam. Beta Lactam is an antibiotic, and prospective candidates will need to be able to work around antibiotics.

Minimum Education:

• Bachelor’s degree in science, engineering, or related areas of study.

Required Experience and Skills:

• At least 8 years' in the pharmaceutical/biotech industry
• Thorough knowledge of plant-wide systems/areas with a minimum of 2 years supervisory experience.
• Must be able 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 applies knowledge of internal/external business challenges to improve products and processes.
• Works independently with minimal guidance
• Solves complex problems and takes a new perspective using existing solutions.
• Builds knowledge of the company, processes, and customers.
• May act as a team or project lead.
• Promotes teamwork and open discussion of issues while coaching and guiding others.

This position requires the following working conditions:

• Work with hazardous chemicals while wearing personal protective equipment.
• As a manufacturer of beta lactam antibiotics, candidates will work in and around the manufacturing and laboratory areas associated with such chemicals.

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

Who we are ...

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for ...

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at [email protected]
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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):

Number of Openings:

Requisition ID:R100254