- Support and ensure the team provides support to the Scientific team to ensure GLP best practices are embedded throughout the site
- Continually review and improve the operation of the Quality function on-site
- Manage a team responsible for the performance of critical phase quality audits for GLP studies
- Serve as the primary Quality resource and provide strong leadership in support of GLP Quality systems, such as Deviations, Change Control, CAPA and Risk Assessment
- Provide direct support for activities related to participation in Regulatory Agency inspections and client audits
- Track Quality Metrics and provide feedback and results to executive staff regarding key Quality related initiatives of continuous improvement, ensuring best practices
- Review and negotiate client Quality Agreements
- Interact with other functional areas to define and execute project requirements and objectives and maintain compliance across the site
- Help to maintain the facility in an inspection ready state for Regulatory Agency inspections and client audits
- Minimum fifteen years' experience working within the pharmaceutical or biotechnology industry, in a GLP environment in a Quality Assurance management role
- Experience in an in-vivo setting would be an advantage.
- ISO 9001:2015 Quality Systems experience a plus
- CRO experience a plus
- Minimum Bachelor's degree in a scientific field or other related subject
- Experience in Regulatory Inspection participation is required.
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Quality Assurance Associate Director - Carlsbad, CA, United States - Pharmaron Beijing Co. Ltd.
1 month ago
Description
Are you ready to embark on an exciting journey with a company that's passionate about making a difference?
Look no further - As Pharmaron continue to grow, we are seeking to add a highly skilled and experienced Quality Assurance Associate Director to join our team to play a key role in the implementation of our quality culture and ensure compliance with Standard Operating Procedures.
This role is an onsite position based in Carlsbad, CA.
What you will do:
As a Quality Assurance Associate Director , you will use your leadership skills to direct a team of Quality professionals and ensure the quality department remains engaged and motivated. You will also Mentor Quality personnel in review of technical GLP study documentation
In addition:
What We are Looking for:
Your expertise in QA within a GLP environment, excellent interpersonal and communication skills and exceptional attention to detail; are abilities that will drive success in this role.
Qualifications and Experience:
Why Pharmaron?
Pharmaron is a premier contract research organization that offers a broad spectrum of R&D and manufacturing service capabilities throughout the entire drug discovery, preclinical, clinical development and commercialization process. With a workforce of over 20,000 professionals and operations spanning the U.S., U.K and China.
Our Culture: You'll thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners and collaborators.
Your benefit package: As part of our commitment to your well-being, we offer a comprehensive benefits package, including medical, dental, and vision insurance with significant employer contributions.
Planning for your future is made easier with our 401k plan and employer match. Plus, you'll have access to an Employee Assistance Program to support you in work and life.
Actual compensation may vary depending on job-related factors including knowledge, skills, and experience.
EEO/AA Statement:
As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.
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