Abbott Associate Director Regulatory Affairs in Abbott Park, Illinois
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Primary Job Function:
Establish and maintain the EPD (Established Pharmaceutical Division) RA (Regulatory Affairs) Quality System
Establish and maintain training documentation system
Develop and maintain metrics for EPD RA training compliance
Audit and Inspection Administrator and other support
EPD RA Management Review
EPD RA Records Operations Center (ROC) Record Archive Management and oversight
Core Job Responsibilities:
Develop and implement quality system documents (policy, process, procedure, instructions, etc.)
Develop business processes, participate in business process teams, and recommend and implement process improvements
Develop and implement supporting training material as needed
Conduct quality checks as needed
Establish and maintain deviation and exception process for EPD RA
Serve as EPD RA representative and approver for cross-functional/cross-divisional quality system documentation
Oversight of training curricula and training plans
Ensure training plans are in alignment with quality system document requirements
Support audits and inspections involving EPD RA
Serve as inspection administrator for EPD Regulatory Affairs audits or inspections
Manage and maintain oversight of EPD RA ROC activities, internal cross-functional support, and third party record sharing arrangements
Responsible for the EPD RA Quality System, its related compliance training, and Regulatory audits and/or inspections.
Collaboration with other EPD quality system functional areas.
Interactions with external auditors/inspectors, as needed.
Oversight and management of external consultants/contractors, as needed.
Oversight and management of EPD physical record and related electronic records for EPD RA and other supported EPD functions.
Bachelor’s degree, preferably in a science, business, or technical field.
Minimum Experience/Training Required:
Excellent verbal and written communication skills, interpersonal skills, and project management skills. Solid English language ability. At least 5 years in the pharmaceutical or related industry. Global experience is a must. Experience writing and maintaining global quality system documents and training experience. Management experience required. Demonstrated problem-solving and decision-making abilities.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org