Sr Director, Quality Assurance NAM
Sr Director, Quality Assurance NAM
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Salary Not Disclosed
1 Vacancy
Job Description
The Sr. Director Quality Assurance will provide quality leadership to the Health & Nutrition Life Sciences North America business to ensure compliance with regulatory authority requirements and to ensure sites are meeting or exceeding customer quality expectations.
- Provide strategic leadership to the Quality group for sustained quality system programs with a continuous focus on improvement
- Lead and inspire the Quality Function by establishing Quality policies that are uniformly deployed across the business
- Educate motivate and empower employees across all functions and operations in the development of a Customer-Focused Quality Culture
- Ensure that processes needed for the QMS are effectively established implemented and effectively maintained; reporting to executive management on the performance and effectiveness of the QMS for review and any need for improvement
- Ensure the promotion of awareness of applicable regulatory requirements and QMS requirements throughout the organization
- Ensure that all sites are inspection or audit-ready and support global regulatory inspections and third-party audit program
- Trend analyze and report on QMS compliance and performance to the Global Head of Quality
- Identify critical compliance and/or business issues related to quality. Create and execute remediation strategies and tactical plans as needed using a risk management-based approach
- Develop strategically and operationally effective response plans to Third Party/Customer audit findings
- Conduct investigations and internal audits on behalf of the Global Quality Excellence team
- Identify and immediately report potential risks that may impact service and the business
Qualifications :
- Four-year degree from an accredited college or university
- In-depth knowledge and experience managing GMP
- 15 years of experience working in Quality Assurance int eh pharmaceutical industry
- 7 years of managing Quality Assurance teams at the Director level
- Demonstrated communication leadership and management skills
- Track record in successfully hosting FDA and Health Authority inspections
- Track record of strong personal performance combined with demonstrated ability to build and lead high performing teams in a fast growing dynamic environment
- Demonstrated problem solving and critical thinking skills
- Experience in technology transfer and management of contract research operations
- Able to work outside of regular working hours and occasional weekends for travel to lab operations sites
Additional Information :
SGS is an Equal Opportunity Employer and as such we recruit hire train and promote persons in all job classifications without regard to race color religion sex national origin disability age marital status sexual orientation gender identity or expression genetics status as a protected veteran or any other characteristics protected by law.
To perform this job successfully an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge skills and/or abilities required.
This job description should not be construed as an exhaustive statement of duties responsibilities or requirements but a general description of the job. Nothing contained herein restricts the companys rights to assign or reassign duties and responsibilities to this job at any time.
If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability please call for assistance and leave a message. You will receive a call back. Please note this phone number is not for general employment information but is only for individuals who are experiencing difficulty applying for a position due to a disability.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
