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 committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Associate Director within the Quality Assurance Center of Excellence is the 'Voice of Quality' for the Site and is responsible for providing Quality direction and oversight to the WP Site in the management of those areas assigned. The individual is an Advocate for the development, execution and deployment of WP Site and our Manufacturing Division's priorities. The Associate Director drives quality improvement activities and ensures alignment across the site in the execution of their assigned areas. The individual is responsible for the development and maintenance of Quality Systems at the West Point site in accordance with cGMPs and international regulations, our Company's guidelines, procedures, and policies.
The Associate Director supports all Quality and Compliance activities for the Site, ensuring compliance with applicable regulations and our Manufacturing Division QMS standards. The role has particular emphasis on shaping performance expectations with respect to Site QMS for new or revised QMS deployment, Site Quality Council and provides guidance and support to all activities related to Health Authority GMP Inspections, Site Quality Plan and Site Compliance initiatives. Maintains communication and engagement with Quality Council CoPs, coordinates QMS Forum meetings, Quality Council and Compliance Tier. The Associate Director will help the Quality Assurance team in identifying quality and compliance risks in the QMS and in managing the actions to address the risk.
The Associate Director partners with other with peers in Auditing, and CRS and other site groups such as Quality, Operations, Technology.
Key duties and responsibilities:
- Understand and apply regulatory/compliance requirements relative to their role.
- Apply knowledge of internal/external processes to identify and drive improvement opportunities.
- Work independently in an empowered culture with a minimal level of guidance and direction
- Explain difficult issues and works to build alignment around a complex situation.
- Make decisions within guidelines and policies which impact a range of standard and non-standard customer, operational, project or support activities.
- May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides others.
- Provide information for regulatory inspections as needed.
- Potential opportunity to support other areas within our West Point Quality Assurance.
- Provide strong leadership for the Quality Management System
- Coordinate and facilitate Site Quality council and monitor and measure effectiveness
- Coordinate, issue and track Site Quality Plan
- Maintain engagement with Regional Compliance Lead
- Support effective management of QMS and continuous improvement actions to achieve permanent inspection ready state
- Participate and support inspections, audits and responses
Education Minimum Requirement:
- Bachelor's Degree or higher in Science, Engineering or another technical field or equivalent experience in the pharmaceutical industry.
Required Experience and Skills:
- Minimum six (6) years’ experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain
- Strong understanding of CGMPs, FDA, and EMEA regulatory standards and strong compliance mindset.
- Proven analytical aptitude, critical thinking skills, and ability to apply key concepts
Preferred Experience and Skills:
- Compliance - Responsible for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business. Responsible for establishing a Right First Time culture by reducing waste and constantly driving continuous improvement. Responsible to author, review and/or approve compliance documents, as per procedures or need. Has experience and ability to achieve compliance goals, through a risk based approach has a deep understanding of GMP and EHS compliance and compliance risk.
- Working Across Boundaries – Must possess excellent interpersonal, communication, collaboration, negotiation to work outside boundaries as a norm
- Business Outcomes /Drive Results – Ability to use deep knowledge and expertise in production operations to drive results and business outcomes
- Demonstrated experience of interacting with site, divisional or regulatory audits
- Demonstrated ability to create an engaged workforce using Inclusion as the How
- Demonstrated knowledge of High Performing Organization tools and methodology, including Lean processing and Inclusion. Our Company's Production System experience - LSS Green Belt certification or equivalent experience.
- Demonstrated success with Talent Management including leading and mentoring
- Proven ability to manage multiple projects simultaneously.
- Applies knowledge of internal/external business challenges to improve products, processes or services.
- Solves complex problems; takes a new perspective using existing solutions.
- Works independently, receives minimal guidance.
- Demonstrated self-starter with capability to develop innovative solutions to challenges.
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 …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
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.
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.
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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.
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