Associate Director, Quality Systems

4 days ago

West Point, United States Merck Sharp & Dohme Full time

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.

**Position Responsibilities**:

- The Associate Director is responsible for performing comprehensive and detailed GMP compliance audits of human health sites, animal health sites, contractors, business partners, and suppliers.
- Support new business opportunities through the performance of due diligence, pre-contract, and Pre-PAI audits.
- Responsible for accepting audit assignments, performing audit pre-work, conducting audits, and write-up of audit reports within defined timeframes.
- Maintain an understanding our company policies, procedures, and guidelines.
- Maintain awareness of evolving industry and regulatory trends/regulations.
- Obtain and maintaining auditor qualification through on-going training and continuing education programs to enable the performance of successful audits
- Coordinate with Site Quality leads on audit refusals and postponements.
- Lead project initiatives, as assigned, to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet site, management, and regulatory expectations

**Education Minimum Requirement and Experience**:

- Bachelor’s degree in science (BS) in Chemistry, (Micro-) Biology, Engineering (or equivalent) with ten (10) years’ experience performing audits and/or quality operations experience. **OR**:

- Master’s degree in science (MS) in Chemistry, (Micro-) Biology, Engineering (or equivalent) with eight (8) years' experience performing audits and/or quality operations experience.

**Required Experience and Skills**:

- Thorough understanding of Quality Management Systems and process to support the manufacturing of drug substances, drugs products, and medical devices.
- Ability to work independently with limited supervision in a virtual-management environment.
- Excellent communication, negotiation, influencing, and strategic thinking skills.
- Review and approve audit reports (as assigned).
- Must be detail oriented and organized.
- Must be a positive change agent and able to adapt in a dynamic environment.
- Must have the ability to travel globally approximately 50% of the time.

**Preferred Experience and Skills**:

- Extensive experience auditing biologics and vaccine manufacturing sites.
- External engagement in regulatory or industry forums.
- Prior experience at a health authority performing GMP inspections.
- Demonstrated ability to establish and maintain collaborative relationships with key stakeholders.
- Demonstrated ability to lead and drive results for business initiatives.
- Demonstrated ability for process improvement.
- Experience with development, implementation ,and optimization of IT tools to deliver business outcomes.

**Travel Expectation**:

- Minimum 50% travel

**NOTICE** **FOR** **INTERNAL** **APPLICANTS**

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.

**Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.**

**US and Puerto Rico Residents Only**:
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualifie

  • Associate Director, Laboratory Quality Assurance

    3 weeks ago

    West Point, United States Merck Sharp & Dohme Full time

    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...

  • Associate Director, Quality Operations

    2 weeks ago

    West Point, United States Merck Sharp & Dohme Full time

    The Associate Director drives quality improvement activities and ensures alignment across the execution of their assigned areas and is accountable for the development and maintenance of Quality Systems in particular the execution of wash, assembly, and sterilization of components in accordance with cGMPs, international regulations and our Company Quality...

  • Quality Management System Director

    4 weeks ago

    West Lafayette, United States Inari Agriculture Full time

    About Inari...Inari is the SEEDesign™ company. We embrace the diversity and complexity of nature in every aspect of our business to drive innovation - to push the boundaries of what is possible. Through our unrivaled technology platform, Inari uses predictive design and advanced multiplex gene editing to develop step-change products. We are taking a nature...

  • Quality Management System Director

    2 months ago

    West Lafayette, United States Inari Full time

    About Inari... Inari is the SEEDesign company. We embrace the diversity and complexity of nature in every aspect of our business to drive innovation - to push the boundaries of what is possible. Through our unrivaled technology platform, Inari uses predictive design and advanced multiplex gene editing to develop step-change products. We are taking a nature...

  • Associate Athletics Director, Compliance

    1 month ago

    West Point, United States Conduct Detrimental LLC. Full time

    Work Conditions & Physical Requirements Perform duties in a fast-paced, ever-changing work environment. Must be able to remain in a stationary position for 75% of the time. Occasionally moves boxes weighing up to up to 30 lbs. The person in this position needs to occasionally move about inside the office to access file cabinets, office machinery,...

  • Associate Athletics Director, Compliance

    4 weeks ago

    West Point, United States Conduct Detrimental LLC. Full time

    Work Conditions & Physical Requirements Perform duties in a fast-paced, ever-changing work environment. Must be able to remain in a stationary position for 75% of the time. Occasionally moves boxes weighing up to up to 30 lbs. The person in this position needs to occasionally move about inside the office to access file cabinets, office machinery,...

  • Associate Athletics Director, Compliance

    1 week ago

    West Point, Mississippi, United States Conduct Detrimental LLC. Full time

    Work Conditions & Physical RequirementsPerform duties in a fast-paced, ever-changing work environment.Must be able to remain in a stationary position for 75% of the time.Occasionally moves boxes weighing up to up to 30 lbs.The person in this position needs to occasionally move about inside the office to access file cabinets, office machinery, etc.Constantly...

  • Associate Director, Project Management

    3 weeks ago

    West Point, United States Merck Sharp & Dohme Full time

    **Position Description**: **Associate Director, Project Management** As an Associate Director in the Nonclinical Drug Safety (NDS) Program Coordination and Planning group, the incumbent will be responsible for partnering with Discovery Program Leaders (Discovery Team Reps), Compound Leaders (Early Development and Product Development Team Reps), and...

  • Quality Specialist

    4 weeks ago

    West Point, United States Merck Sharp & Dohme Full time

    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...

  • Associate Director, Tech Transfer Leader

    2 months ago

    West Point, United States Merck Sharp & Dohme Full time

    As part of our Company Manufacturing Division, within Global Science Engineering & Commercialization, the Large Molecule Science and Technology (LMS&T) is accountable for Large Molecule Commercialization, Technical Product Leadership and Technical Operations. We are seeking a highly motivated individual for the role of Associate Director, Tech Transfer...

  • Quality Director

    6 days ago

    West Valley City, United States Scientia Vascular, LLC Full time

    Job Description Job Description Our mission is to save lives. Scientia Vascular is a leading innovator and manufacturer of endovascular medical devices. We use micromachining and microfabrication processes to manufacture products that provide physicians with enhanced performance for optimal outcomes for their patients. Quality Director Job Description Lead...

  • Director, Quality Assurance

    3 weeks ago

    West Point, United States Merck Sharp & Dohme Full time

    We are seeking an exceptional scientific leader for the role of Director, Quality Assurance in the Biologics/Vaccine Development Quality group, located in West Point, PA. Biologics/Vaccine Development Quality (BVDQ) within Global Development Quality is responsible for technical, operational and strategic quality oversight of a growing and fast moving large...

  • Quality Associate/Data Entry Specialist

    1 month ago

    West Union, United States HNM Systems, Inc. Full time

    Job DescriptionJob DescriptionIdentified as one of the top 100 fastest growing private businesses in San Diego by the SD Business Journal, HNM Systems is a rapidly growing, people-driven Communication Information and Emerging Technology staffing and consulting firm.DescriptionBe a part of shaping our future. In the midst of rapidly growing populations,...

  • Quality Associate/Data Entry Specialist

    4 weeks ago

    West Union, United States HNM Systems, Inc. Full time

    Job DescriptionJob DescriptionIdentified as one of the top 100 fastest growing private businesses in San Diego by the SD Business Journal, HNM Systems is a rapidly growing, people-driven Communication Information and Emerging Technology staffing and consulting firm.DescriptionBe a part of shaping our future. In the midst of rapidly growing populations,...

  • Quality Director

    2 weeks ago

    West Valley City, United States SCIENTIA VASCULAR INC Full time

    Job DescriptionJob DescriptionOur mission is to save lives. Scientia Vascular is a leading innovator and manufacturer of endovascular medical devices. We use micromachining and microfabrication processes to manufacture products that provide physicians with enhanced performance for optimal outcomes for their patients.Quality Director Job DescriptionLead the...

  • Complaints Specialist, Quality

    3 weeks ago

    West Point, United States Merck Sharp & Dohme Full time

    **Position Overview - Basic Functions & Responsibility** **The Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Product Team). With guidance from the Associate Director of Quality Operations, the Quality Specialist ensures quality and compliance of products manufactured by the functional area,...

  • Director of Quality

    2 weeks ago

    Crown Point, United States Vaco Full time

    Overview: The Director of Quality will lead quality improvement and assurance initiatives, ensuring the highest standards of care and service. The role involves developing and managing programs and strategies for quality improvement, with a focus on healthcare quality management, leadership, and continuous improvement. Key Responsibilities: Quality...

  • Director of Quality

    1 week ago

    Crown Point, Indiana, United States Vaco Full time

    Overview:The Director of Quality will lead quality improvement and assurance initiatives, ensuring the highest standards of care and service. The role involves developing and managing programs and strategies for quality improvement, with a focus on healthcare quality management, leadership, and continuous improvement.Key Responsibilities:Quality Improvement...

  • Director of Quality

    2 weeks ago

    Crown Point, United States Vaco Full time

    Overview: The Director of Quality will lead quality improvement and assurance initiatives, ensuring the highest standards of care and service. The role involves developing and managing programs and strategies for quality improvement, with a focus on healthcare quality management, leadership, and continuous improvement. Key Responsibilities: Quality...

  • Associate Director, HR Data Privacy and M&a

    1 week ago

    West Point, United States Merck Sharp & Dohme Full time

    The Associate Director, HR Privacy and Merger / Acquisition (M&A) is responsible for the oversight and management of HR data privacy and is responsible for the oversight of mergers, acquisitions, and divestitures related to HR systems. This individual serves as the lead for all activities related to HR systems compliance with global data privacy...