Opportunity Profile:
Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest – and highest quality – product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's third-largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. We are currently seeking a Manager, Global Change Control in our Global Quality department at our Morgantown, WV location.
In this exciting role, the candidate will provide management, organization, guidance, and hands-on assistance to oversee the implementation of a standardized Global Change Control Program. The successful candidate will assist the Director with the development and/or improvement of programs by defining requirements established via in-depth review of existing systems, strategic direction and regulatory compliance expertise.
Additional responsibilities include:
1. Provide global oversight of standardized change control process.
2. Evaluate existing change control systems worldwide.
3. Maintain and build-up quality contacts throughout Mylan.
4. Develop short-term and long-term harmonization and remediation strategies with associated timelines, cost projections, and outcomes.
5. Assist in development of a standard database for change control management.
6. Directly manage Quality Change Control Database Administrator.
7. Maintain and enhance Good organizational, people and program management, and budget management skills.
8. Work with Quality on a global level to assess immediate needs for change control and long-term strategies for change control management.
9. Assist in development and implementation of a validated database to support global aggregation, reporting, and assessment of critical data and key performance metrics.
10. Maintain and enhance a validated system/database to assure quality compliance and continuous process improvement.
11. Review, approve, and route change control requests.
12. Perform independent research of required topics and FDA, EMEA, TGA, Health Canada, WHO, PIC/S, MHLW, and other national, international, or supranational regulations (ICH, GxP etc) including assessment of applicability and impact on change control.
13. Provide independent review, comprehension, and discussion of departmental and corporate policies and procedures with multiple levels of employees and Management.
14. Provide interpretation of complex regulations through research of current corporate and governmental expectations.
15. Facilitate meetings with all levels of Management.
16. Prepare all associated system validation documentation including assessment reports, project plans, validation strategy documentation, global quality directives, user requirements, installation qualification, operation qualification, performance qualification, and validation summary reports under set timelines.
17. Track and monitor system validation.
18. Perform training of key and required personnel.
19. Plan, schedule, and arrange travel to various sites based upon guidance from Management.
*Requires domestic and international travel.
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