Deviation Manager- West Chester, OH- Operations
Deviation Manager- West Chester, OH- Operations
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 very 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 Deviation Manager is responsible for overseeing the Lead Investigation Team as well as performing investigations and driving each event to conclusion by working with others. The Deviation Manager ensures the investigation outcome and root cause analysis are completed in a timely, effective, and compliant manner. The speed and rigor demonstrated by this role will drive a culture that prevents unplanned deviations through a robust and proactive investigation process. As Business Process Owner (BPO) of both deviations and investigations, this individual is responsible for educating the site on the process, maintaining procedures and metrics, and representing the site in relevant cross-site forums. The Deviation Manager is the owner of all deviation related Key Process Indicators (KPIs).
What you’ll do:
- Conducts organized investigations with a well-defined scope, strategy, and timeline documenting status and progress of the investigation and CAPAs.
- Authors reports that document the investigation of issues including definition, scope, product impact, root cause, and corrective actions to prevent the recurrence of the issue.
- Seeks and leverages the skills and technical expertise of internal and external resources to improve the speed and rigor of investigations.
- Collaborates with a cross functional team to determine:
- Communication strategy so all stakeholders have appropriate information.
- Investigation strategy including a clear and actionable problem statement.
- Investigation tools, action plan and timing.
- Root cause.
- Solution selection.
- CAPA action plan and effectiveness checks.
- Prioritizes Lead Investigator’s work tasks to aid in timely decisions and completion of investigations. Escalates issues as appropriate.
- Works within and across functions, sites, and regions to ensure connectivity of investigations between functional areas and sites.
- Coaches, trains, and develops direct reports to optimize performance outcomes ensure individuals understand the contribution they make.
- Promotes and encourages continuous improvement in efficiency, quality, production, and safety through the use of team driven processes and key performance indicators and recognition and rewarding high performance.
Essential for the role:
- Bachelor’s degree required, preferably in Science, Engineering, or other related technical discipline.
- Minimum five years in Pharmaceutical Manufacturing and/or other similar regulated industry.
- Ability to quickly assess and assimilate technical data and conduct a thorough investigation; ability to present findings, conclusions, and complex information in a clear, concise, and logical manner.
- Excellent technical writing, verbal, and presentation skills.
- Thorough understanding of the internal core business process including relevant cGMP and regulatory. Adept at identifying and understanding the critical factors in order to generate appropriate solutions.
- Attention to detail and data integrity is essential. Ability to monitor activities to accomplish stated objectives in an effective manner.
- Must be able to work in a fast-paced and rapidly changing environment. Ability to prioritize work activities to meet customer needs and deadlines.
- Must be proficient with Microsoft Office Suite and have a working knowledge, or the ability to learn, computer systems such as TrackWise, SAP, LIMS, and Electronic Batch Record Systems.
- Must be able to take accountability with excellent follow up and follow through; owns issues through the full cycle investigation process.
- Experience with Quality Management Deviations.
- Experience with Lean problem-solving tools.
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.