Director, Compliance and Quality Systems- West Chester, OH- Operations
Director, Compliance and Quality Systems- West Chester, OH
Would you like to apply your expertise to impact the Quality Operations in a company that follows the science and turns ideas into life changing medicines? At AstraZeneca, we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. As the voice of the patient, every batch we certify is a personal stamp of approval. A place to take Quality seriously - we draw findings from others to develop and understand what it takes to drive our modern approach forward. Here you’ll feel empowered to step up, follow the science and evidence to make decisions that put patients first.
Our West Chester Supply Site is a multifaceted and growing manufacturing site within the AstraZeneca Global Operations network and is located just north of Cincinnati, Ohio. In addition to serving as the global COVID vaccine production site for AstraZeneca, the West Chester site encompasses Bulk API Microsphere manufacturing, Aseptic Pharmaceutical Formulation, multi-line Isolator/Barrier Vial and Syringe Filling, and specialty Packaging Operations for Vials and Auto-Injectors that supports growing franchises in Diabetes and Respiratory. Our site is one of 30 production facilities in 18 countries with over 700 people collaborating to connect powerful medications to patients in more than 60 countries around the world. We focus on providing a collaborative environment where everyone feels comfortable and able to be themselves. Being able to bring your full self to work every day is at the core of AstraZeneca’s priorities. On-site amenities include a Health and Wellness clinic, as well as a Cafeteria Grille serving breakfast and lunch items for employees and guests.
The Director of Compliance and Quality Systems is a senior level leadership position within the Quality organization and is critical in establishing an operating model that protects AZ’s reputation, product supply and license to operate. You will lead cGMP Compliance & Quality Systems at the supply site, maintain knowledge of, and implement, current cGMP regulations, AZ Quality & Compliance policies, and industry best practices for Quality Systems. This role will ensure compliance with regulatory filings and regulatory agency reporting, and the implementation of compliance site initiatives and procedures.
The leader of this area will be the principle contact for inspections by regulatory agencies, Global Operations Quality and external customers. The role will have responsibility for managing a staff of Compliance and Quality professionals and will also serve as a member of the site Quality Leadership Team (QLT).
What you’ll do:
- Leads efforts at the sites and influences the regional and global Quality organization to create policy, provide guidance and influence senior Leaders in the area of GMP compliance.
- Accountable for being an influencing Leader with external regulators and key industry organizations such as ISPE, PDA and ASQ.
- Provides the necessary leadership to create a vision, mission and road map for creating a culture of Quality and Compliance that is well integrated and supportive of end-to-end supply.
- Provides Leadership and collaboration that engenders a culture of cross-site collaboration and fosters a very transparent and respectful approach with regulators in order to advance AZ’s influence and reputation.
- Leads, coaches, mentors and develops a team of Quality and Compliance professionals. Responsibilities include staffing, prioritization of work, performance management, and personnel development.
- Leads site Compliance meetings and programs and ensures consistent execution of Quality Systems, and drives the efficiency and effectiveness of current compliance programs and quality systems across site PETs and services groups, as appropriate, including:
- Deviation Management and CAPA
- Product Quality Complaints
- Change Control
- Quality Risk Management
- GMP Documentation
- Regulatory Program Management (Field Alert, APR’s, Inspections, Compliance Improvement Plans, Site Master Plans etc)
- Product Quality Reviews
- Supports continuous improvements efforts for computerized applications to key Quality System (e.g., Trackwise)
- Responsible for the site’s QADC and Records Management departments.
- Leads efforts to identify evolving regulatory and industry initiatives relating to compliance and quality systems and ensure proactive involvement of site. Actively participate in outside industry and professional associations, and influence these groups to adopt practices favorable to AZ.
Essential for the role:
- Bachelor’s degree, preferably in a science/technical field such as Pharmacy, Biology, Chemistry or Engineering.
- Seven (7) years or more of experience in the pharmaceutical industry.
- Previous leadership or management experience in a Quality or Compliance position.
- Extensive knowledge working in an aseptic/sterile environment.
- Advanced knowledge of cGMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies.
- Demonstrated ability to influence leaders in a matrix environment and the personal conviction to make courageous decisions to ensure patient safety and to protect company reputation
- Advanced degree, Masters or higher.
- Seven (7) years or more in supervisory/managerial roles within QA in the Pharmaceutical Industry.
- Multiple site or function experience.
- Experience interacting with third parties (e.g., contract service providers) is preferred. Strong auditing skills required with ASQC certification desirable.
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial -finding those moments and recognizing their potential. Interested? Come and join our journey!
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.