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 requirements. 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.
The Quality Systems Manager will have leadership responsibility for the site Quality Management System (QMS) program, encompassing the full scope of site operations. Collaboration is required with site leadership and regional compliance leadership to ensure management of the site QMS and to ensure compliance with our company’s Global Manufacturing Division requirements and procedures. The position requires ability to lead and perform the operational aspects of the QMS program, apply risk-based principles, communicate results to stakeholders, and manage the site’s documentation system.
Primary Activities
- Manage and oversee the site’s QMS ensuring compliance with QMS requirements and procedures. Review and approve documents as defined by QMS documents.
- Establish and approve local Standard Operating Procedures (SOPs) that impact product quality. Ensure they conform to QMS documents
- Ensure a documentation system is in place and compliant with requirements. Act as site Midas Steward or equivalent documentation system steward
- Management of site archives and retained sample archives
- Review and approve Validation Master Plans and documentation for qualification and validation activities including those associated with computerized systems in accordance with defined procedures
- Act as site Quality Risk Management (QRM) Champion and ensure processes and procedures are implemented and executed as per established QRM requirements
- Ensure monitoring of the site QMS performance including oversight and governance of the feedback loop for continuous improvements
- Manage Quality Agreements in line with established procedures
- Manage customer complaints in line with established procedures
- Manage Annual Product reviews in line with established procedures. Utilize annual data to identity system or process improvements and ensure their implementation, as appropriate.
- Ensure that a system is in place to manage CAPA activities including generation, investigation, documentation, implementation, verification, closure, effectiveness and trending
- Ensure that a system is in place to manage customer complaints and investigations
- Oversee preparation of packaging component testing documentation and related specifications and supervision of component testing and release
- Management of site reject system and documentation
- Ensure site stability program is adhered to
- Ensure Mock recall activities are carried out annually
- Act as Quality Council co-ordinator back up
- Act as Change owner/ approver for site changes using the GCM Trackwise or equivalent system
- Approve Purchase orders on SAP
- Participates in MPS Lean activities
- Participates in continuous improvement projects within the department and in collaboration with the site.
- Ensures that safety rules are adhered to and that the Safety SOP’s are maintained and followed
- Responsible for reporting adverse experiences or events (AEs), adverse device events (ADEs) , product quality complaints (PQCs) and other reportable information, customer feedback (CF), alleged counterfeiting, diversion and tampering (CDT) that you become aware of to the Designated Point of Contact (DPOC)
Qualifications/ skills
- Minimum tertiary qualification in Pharmacy or related BSc field.
- Knowledge of pharmaceutical Good Manufacturing Practices and regulatory requirements
- Problem solving skills. Able to deal with situations requiring interpretative and evaluative thinking. Able to make unbiased and honest judgements
- Good people leadership skills
- Proficiency in use of Microsoft Word, Excel software, Power Point, MS Teams
- Ability to work independently with limited supervision
- Ability to build relationships and influence across disciplines at all levels
- Teamwork skills and flexibility
- Takes initiative
- Good oral and written communication essential
Experience required
Minimum of 5-8 years in Quality Assurance, technology & Validation and/or manufacturing operations experience within GMP environment
Advanced understanding of GMP, particularly with reference to packaging operations
Ability to lead and participate in both local and international Health Authority Inspections.
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.
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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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:
Regular
Relocation:
No relocation
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Requisition ID:R95200