Regulatory Job AD Business Process Compliance

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AD Business Process Compliance MA Open (J#24922)
Education: Bachelors Degree
Experience: 10 - 20 years

Genzyme Corporation, ranked as one of the foremost biotechnology companies in the world, is committed to providing an exceptional environment in which individuals can excel, and achieve their professional and personal goals. Genzyme Corporation has been selected by FORTUNE magazine as one of the "100 Best Companies to Work For in 2007 in the United States. By applying for a position with Genzyme, you are taking the first step toward becoming a part of our dynamic and talented team, and sharing in our continued success.

JOB TITLE: Associate Director, Business Process Compliance - Corporate Quality Systems

DEPARTMENT: Corporate Quality Systems

REPORTS TO: Senior Director, Corporate Quality Systems

Job Responsibilities/Department description:

Lead Genzyme businesses and functions in the development, management, measurement, and improvement of key regulatory compliance and business processes and management systems.

Manage the global events process and other defined global compliance processes to include regulatory intelligence, performance measurement, management review, corrective action, information systems management, and global documentation.

Develop and implement regulatory compliance standards and policies across Genzyme businesses and sites including measurement systems to monitor performance.

MAIN DUTIES:

1. Manage the Global Events Process and the GEMG Team.
2. Manage global, cross-functional/corporate regulatory compliance and business processes based on Genzyme senior stakeholder needs.
3. Assist the corporation in the improvement of select compliance processes.
4. Develop and expand of the 5-star for quality program. Support the design of regulatory compliance criteria and policy with subject matter experts where applicable.
5. Assist in the development and implementation of global regulatory compliance policies, guidelines, and measurement.
6. Support Genzyme Canada in the development and management of its quality management system. Ensure it is compliant with local and International Oversight Committee requirements.
7. Assist in the sharing of results, practices, and improvement areas between Genzyme sites and offices via councils, forums, global meetings, etc.
8. Participate and provide input into the development of strategy, planning, and implementation of actions/initiatives to improve Genzymes regulatory compliance levels and key business performance indicators.
9. Assist in the determination of corporate-wide compliance objectives and establishment of global compliance strategy.
10. Utilize data and reporting to monitor and track results where applicable. Benchmark performance against key indicators within and outside the industry where applicable.
11. Manage the Global Regulatory Compliance documentation system.
12. Hire, develop and train department staff as appropriate, providing timely and appropriate performance feedback. Assist with department structure decisions. Ensure that staff competencies remain current with industry sector changes.
13. Participate in departmental planning and budgeting and ensure budgets and resources are managed appropriately.
14. This position will require approximately 10% travel both domesticaly and internationally.

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