
Director, Quality Assurance
Welcome to Merck & Co., a global healthcare company that has been dedicated to improving lives since 1891. We are seeking a highly experienced Director of Quality Assurance to join our team and lead the way in ensuring the safety, efficacy, and quality of our products. As the Director of Quality Assurance, you will play a critical role in upholding our commitment to delivering high-quality medicines and vaccines to patients all around the world. We are looking for a dynamic and driven individual with a strong background in quality assurance and a passion for driving continuous improvement. If you are ready to make a difference and contribute to our mission of saving and improving lives, we encourage you to apply.
- Develop and implement quality assurance strategies and processes to ensure compliance with regulatory standards and company policies.
- Monitor and evaluate all aspects of product development, including manufacturing, testing, and packaging, to ensure quality and safety.
- Collaborate with cross-functional teams to identify and address potential quality issues and drive continuous improvement initiatives.
- Oversee the qualification and validation processes for equipment, systems, and procedures used in the manufacturing and testing of products.
- Establish and maintain relationships with regulatory agencies and participate in audits and inspections.
- Lead a team of quality assurance professionals, providing guidance, training, and development opportunities.
- Develop and maintain quality metrics and reports to track performance and identify areas for improvement.
- Ensure all products meet quality and safety standards before being released to market.
- Stay current with industry trends and regulatory requirements, making recommendations for process improvements as needed.
- Conduct risk assessments and implement risk mitigation strategies to minimize quality and safety risks.
- Manage and maintain the company's Quality Management System (QMS).
- Collaborate with other departments, such as research and development and supply chain, to ensure quality standards are met throughout the product lifecycle.
- Lead and participate in cross-functional teams to address quality issues and implement corrective and preventive actions.
- Act as a subject matter expert on quality assurance for the company, providing guidance and support to other departments as needed.
- Foster a culture of quality and continuous improvement throughout the organization.
Excellent Communication And Interpersonal Skills, With The Ability To Effectively Collaborate With Internal And External Stakeholders At All Levels Of The Organization.
Bachelor's Or Master's Degree In A Relevant Field Such As Pharmaceutical Sciences, Chemistry, Or Biology
Minimum Of 10 Years Of Experience In Quality Assurance Within The Pharmaceutical Industry
Strong Knowledge Of Current Industry Regulations And Standards, Including Fda, Ich, And Gmp
Demonstrated Leadership And Management Skills, With Experience In Leading Cross-Functional Teams And Developing Quality Assurance Strategies
Process Improvement
Data Analysis
Quality Management
GMP Knowledge
Auditing
Quality Control
Team Leadership
Risk assessment
Regulatory compliance
Problem-Solving
SOP Development
Project
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
creativity
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Director, Quality Assurance in West Point, PA, USA is $130,000-$160,000 per year. This can vary depending on the specific industry, company size, and level of experience of the individual.
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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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