
Associate Director, Combination Product Quality Engineering and Quality Assurance
Are you a highly experienced Quality Engineering and Quality Assurance professional with a passion for ensuring the safety and efficacy of combination products? Look no further! Merck & Co. is seeking an Associate Director to lead our Combination Product Quality Engineering and Quality Assurance team. In this role, you will play a critical role in ensuring the quality and compliance of our combination products throughout their lifecycle. We are looking for a driven and detail-oriented individual with a strong technical background and leadership skills. If you are ready to join a dynamic and innovative company dedicated to improving patients' lives, we encourage you to apply!
- Lead and manage the Combination Product Quality Engineering and Quality Assurance team at Merck & Co.
- Ensure the safety and efficacy of combination products through all stages of their lifecycle.
- Develop and implement quality systems and processes for combination products in accordance with industry standards and regulations.
- Stay updated on relevant regulations and guidelines related to combination products and ensure compliance within the team.
- Collaborate with cross-functional teams to identify and resolve quality issues in a timely manner.
- Conduct risk assessments and implement mitigation strategies for potential quality and compliance issues.
- Supervise and mentor team members to ensure their professional development and growth.
- Work closely with manufacturing and supply chain teams to ensure quality standards are met during production and distribution of combination products.
- Conduct internal and external audits to assess and improve the quality and compliance of combination products.
- Act as a subject matter expert and provide guidance on quality engineering and quality assurance processes to other departments within the company.
- Evaluate and implement new technologies and techniques to improve the quality and efficiency of combination product development and manufacturing.
- Communicate regularly with senior management to provide updates on the team's performance and any potential quality issues.
- Foster a culture of continuous improvement and quality excellence within the team and the company.
- Ensure all combination products meet regulatory requirements and are in compliance with company policies and procedures.
- Represent the company in interactions with regulatory agencies and participate in audits and inspections.
Bachelor's Or Master's Degree In Engineering, Science, Or Related Field.
Minimum Of 8 Years Of Experience In Combination Product Quality Engineering And Quality Assurance Within The Pharmaceutical Or Medical Device Industry.
Strong Knowledge Of Fda And International Regulations And Guidelines Related To Combination Products.
Demonstrated Experience In Leading And Managing Cross-Functional Teams And Projects.
Excellent Communication, Problem-Solving, And Decision-Making Skills With A Focus On Continuous Improvement And Compliance.
Risk Management
Quality Assurance
Process Improvement
Project Management
Quality Systems
Quality Control
Team Leadership
Compliance Management
Regulatory compliance
Supplier management
Engineering management
Product Quality
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Associate Director, Combination Product Quality Engineering and Quality Assurance in North Wales, PA 19454, USA is $130,000 - $160,000 per year. This can vary based on factors such as experience, education, and specific job responsibilities.
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Merck & Co., Inc., d.b.a. Merck Sharp & Dohme outside the United States and Canada, is an American multinational pharmaceutical company and one of the largest pharmaceutical companies in the world. Merck & Co., Inc. engages in the provision of health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products. It operates through the following segments: Pharmaceutical, Animal Health, Alliances and Healthcare Services. The Pharmaceutical segment includes human health pharmaceutical and vaccine products marketed either directly by the company or through joint ventures.

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