Description:
At AbbVie, we offer you the resources and a global reach to empower your innovative mindset. From day one, we’ve known it takes teamwork and collaboration to develop the scientific breakthroughs, innovative pipelines, and therapies that change millions of patients’ lives around the world. In short, we know it takes “you” to make those ground-breaking advancements happen. We take pride in serving and supporting our communities and protecting the environment, making a lasting impact that's felt within healthcare and beyond.
- Provide strategic and tactical direction for Quality Systems design and maintenance.
- Manage key site quality systems such as Change Control, Deviations, CAPAs, Product Quality Reviews, Internal Auditing, Site Quality Reviews, Document Management and Control, Labeling Artwork Approval, Technical Agreements and Site Master File. Measure and report site performance on key indicators of these quality systems through metrics.
- Ensure quality system performance is appropriately and well communicated throughout site. Provide guidance and assessments on other site Quality Systems
- Ensure site applicable aspects of regulatory submissions are appropriately reviewed for consistency between site procedures and methods and regulatory submissions
- Establish the expectation and standards, and the supportive environment, to ensure that staff has the capability to meet performance expectations. This includes building staff capability by providing ongoing coaching and mentoring of direct reports, providing timely recognition as well as performance counseling, building and executing development plans, and providing career counseling for career progression
- Enforce cGMP, safety, housekeeping, and security procedures, maintaining a safe working environment and promptly reporting incidents and accidents to site leadership
- Seek process innovation and continuous process improvement in QA function.
- Develop and sustain a culture of constant site readiness for site inspections. Identify industry trends and implementation strategies to keep the site ahead of the compliance curve and within Allergan’s budgetary requirements
- Bachelor’s Degree or above in Chemistry, Pharmacy or related Science
- Must have excellent understanding of current Good Manufacturing Practices and manufacturing operations
- Demonstrated success in managing a team in a pharmaceutical production environment and providing leadership in a technical environment
- Experienced and knowledgeable in EU and FDA cGMPs
- Experienced in interacting with regulatory authority inspectors
- Experience in managing by metrics
- Experienced in aligning individuals and teams to business objectives
- Exposure to Lean manufacturing concepts