Sets up, leads and develops a team responsible for Quality Control Coordination, Quality Compliance, Exception and Change Management, Qualification and Maintenance and, analytical Outsourcing.
Develops and implements short and mid-term strategy for the Compliance group and manages effectively local and global interfaces (within PDS&T, with Operations QC, R&D and Ops QA, Development Sciences, Regulatory, etc.).
Develops/aligns local processes/workflows and GMP approaches within PDS&T LC
Develops/aligns in close cooperation with other PDS&T sites and partner organizations global lean processes/workflows and GMP approaches cross-functionally.
Manages effectively local/global interfaces (Operations QC, R&D and Ops QA, Development Sciences, Regulatory, etc..) and drives cross-functional alignment. Initiates and/or contributes to global cross-functional initiatives to improve processes and workflows.
Is responsible for GMP systems and processes, and compliance within area.
Drives/coordinates local and global initiatives to align and improve processes and workflows.
Ensures utilization of appropriately risk based approaches to ensure project and internal/external budget success and increase efficiency.
Drives technological innovation and guides improvements to leverage operational excellence within function and in line with the PDS&T vision.
Leadership Competencies:
Is up to date on regulatory expectations (guidelines, GMPs and other GxPs as appropriate) and translates these into executable approaches aligned with partner functions.
Builds strong relationships with peers to create and implement aligned local and global processes and strategies as it relates to area of responsibility.
Motivates and influences others to manage global business partners.
Knows the business to influence long-range strategy.
Creates a learning environment, open to suggestions and experimentation for improvement to recruit, develop and retain top talents.
Deals comfortable with uncertainty, ambiguity and risk making decisions. Ensures alignment with corporate/regulatory policies/standards.
Steps up and takes leadership to implement changes in the face of organizational or personal challenges.
Raises the bar and drives the function to efficient/reliable execution.
Develops long-range plans for resource and capital investments.
Learns fast, grasps the essence and can change course quickly where indicated to manage and prioritize resources & timelines across a wide range of programs and initiatives within area of responsibility.
BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline.
Minimum 5 years of experience in the pharmaceutical industry with exposure to analytical and/or formulation development and funded expertise in GMP areas.
Demonstrated ability to function as a principle investigator, generating original technical ideas and research or development strategies.
Demonstrate creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals.
Recognized and sought out as an expert in his/her discipline within the company and possibly externally.
Experienced and demonstrated success as primary author of publications, presentations, regulatory documents and/or primary inventor of patents.
Demonstrated scientific communication and presentation skills by presenting at leading scientific conferences.
Requirements
Sound knowledge of global GMP requirements and regulations and experience with their implementation in well-defined and efficient processes and workflows.
Prior management and leadership experience are required.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Benefits
Dental insuranceVision insurance401(k)Paid time offPerformance bonus
Abbvie · North Chicago, IL