EQA Senior Specialist/ Product Quality Manager

Job Description

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.

Position Responsibilities:

• Responsible for ensuring that all of our Company products managed by EQA Large Molecule (EQA LM) are manufactured, packaged, tested, released for further processing, stored, and distributed in accordance with our Company expectations and all applicable regulatory requirements.
• Providing product specific Quality Oversight of External Entities and ensures that effective and robust Quality Systems are in place to comply with required regulations, policies and guidelines governing activities at External Entity (EE) sites by means of risk-based quality oversight and on-site supervision, as appropriate.
• The PQM is responsible for batch testing release for further processing by downstream site of all products manufactured at the External Entity site including cell banks, biologic/ vaccine drug intermediates, biologic/vaccine drug substance and drug products.
• The PQM will support External Entity relationships with activities of increasing complexity, scope, and volume which can be influenced by one or more of the following: number of products under oversight, number of sites supported, volumes, number and complexity of markets, historical performance (testing and compliance), new product or market launches, historical relationship between our Company and the External Entity, and process complexity.

Education Minimum Requirement:

• Bachelor Degree in Science.

Required Experience and Skills:

• Minimum of 5 years’ relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
• Must have hands-on experience with change control process and deviations. Communicates in English, both verbally and in writing.
• Must have strong interpersonal, communication, negotiation, and persuasion skills to build strong relationships.

Behavioral Competencies:

• Strategic Thinking (applying), Working Across Boundaries (applying), Project Management (advanced), Problem Solving (advanced), and Productive Communication (advanced).

Technical Competencies:

• Regulatory Standards and Compliance (advanced), Customer and Supplier Management (applying), Quality Risk Management (applying), Quality Audit Management (advanced), Deviation Management (advanced), Inspection Readiness and Management (applying), Quality Management System (applying), Regulatory Standards and Compliance (advanced), Laboratory Testing (advanced), Laboratory Method Development and Validation (advanced), Laboratory Data Information Management (advanced), Production, Processing & Environment Control (applying), Validation & Qualification (advanced), Technical Transfer Oversight (advanced)

Preferred Experience and Skills:

• Experience with biologic and/or vaccine Quality Assurance and Quality Control
• Experience in Contract Manufacturing Oversight (CMOs, Labs, etc.)
• Knowledge of common biologic and/or vaccine manufacturing processes
• Experience with Trackwise change control application
• Experience with COMET SAP for batch disposition, deviation management, CAPA management and PCR Trace

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.

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:R92208