AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases. In 2013, AbbVie will employ approximately 21,000 people worldwide and markets medicines in more than 170 countries.
The Program Manager is responsible for supporting activities related to Combination Products
o Assure integration and support of device regulations, drug regulations and as appropriate, biologic regulations.
o Perform design control activities: Mentor/lead product team members through the design process providing guidance to assure optimal approach. Work closely with research organization to ensure potential product issues are identified and addressed in the design. Assure robust product vs. customer requirements.
o Ensure design control documentation (Traceability/Linkages) & design change control requirements are met. Assess the impact of a change on the safety, efficacy of the combination product/device. Assess the impact of changes as they relate to the regulatory environment. Analyze and justify the impact on cumulative changes and the impact of a change across other products.
o Partner with Third Party Vendors/Manufacturers to ensure that combination products/devices are in compliance with internal and Regulatory Agency standards.
o Perform 3rd party supplier management activities such as review and approval of 3rd party design control activities, assessment of supplier changes, establishment of appropriate balance between internal oversight actions and supplier controls, provide input to quality agreements, perform relationship development, supplier site visits, etc.
The candidate will serve as the QA point of contact on device development teams
The position requires one to
Work on unusually complex technical problems and provide solutions that are highly innovative and ingenious.
Provide consultation & training on specific QA expertise to internal and cross-functional groups.
Resolve project team issues with minimal oversight.
Lead complex global cross-functional process improvement teams.
Have expert knowledge of global regulations, guidances, and Corporate and Division standards.
Serve as an organization spokesperson.
Act as an advisor to management and customers.
Initiate assignments independently.
The individual will interact and have the ability to influence decisions of the various R&D Directors as external customers.
The job requires broad understanding of regulations and standards affecting combination products and devices.
Knowledge of regulatory compliance requirements should include historical perspectives and current trends of the regulatory agencies. The incumbent must have clear leadership skills and have been seen to take a position on Quality issues and standards, and must be capable of clearly and logically justifying such positions. Key leadership competencies are making difficult decisions, relationship-building, influencing, fostering teamwork, knowledge of the business and sound judgment.
