Our West Chester Supply Site is a very dynamic 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, Respiratory, and Vaccines.  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. We also have a Great Place to Work Counsel, involving committees of employees who coordinate several activities related to community outreach, sustainability, health and wellness and social events.

Description:

The Senior Quality Systems Specialist manage and execute GMP compliance programs and provide support to key quality systems and computer applications. Assure compliance through continuous monitoring and evaluation of GMP systems and processes against regulations, pharmacopeias, AstraZeneca policies and procedures. May act as a process owner of one or more quality systems across the site. Host and/or participate in audits by internal assessors and regulatory authorities.

The incumbents will have oversight responsibilities for one or more of the following Quality Systems and the related processes, and procedures across the WCH site:

1. Global Complaint Management System (GAM/S-Life)

2. Track-wise Deviation Management System (IDM)

3. Audit program for local suppliers (SCA)

4. Commercial Stability Management (GQCLIMS)

5. Change Control (OCM)

At this level the incumbent will be fully trained and demonstrate some level of understanding of the major responsibilities of the role (GMP Compliance, Auditing, Computer Validation, Product Complaints, Compliance, and Stability).   The incumbent will also demonstrate proficiency in the Quality System to which the individual is aligned. The incumbent will act as execution lead/process owner for one or more processes.

What you'll do:

• Perform regulatory surveillance, and review of Q&C documents.
• Lead standardized application of quality systems across the site.
• Liaise with US Sites, and Global Quality Operations and support global compliance projects and/or initiatives.
• Develop compliance improvement programs for the site. Lead project teams and programs that are related to compliance, quality systems, and continuous improvement initiatives.
• Participate on Issues Management Teams. Provide compliance advise to complex quality issues. Manage recall process at the site.
• Manage NDA Field Alerts Reports, Deviations and CAPA program.
• Responsible for governance of compliance reporting, and KPIs across the site.
• Establish and maintain the annual audit schedule for local suppliers in coordination with GES. Assist with due diligence audits of new suppliers and/or business partners, as appropriate.
• Manage the preparation and maintenance of Quality Assurance Agreements in support of company initiatives for distribution, licensees, etc. in the US.
• Lead the preparation, planning & logistics, inspection management, and management of formal response and follow-up with internal assessments and Regulatory Inspections.
• System ownership of computerized applications for quality systems across the site (Trackwise, SAC, S-Life, GCM, OCM, GQCLIMS and ANGEL). Ensure consistent application across users at the site.
• Manage major changes, and support users across the site. Administer accounts, system access, permissions for quality system applications, including periodic audit of accounts/users.
• Lead training program for the quality system application.
• Manage compendia compliance across the site. Monitor changes to pharmacopeia requirements.
• Quality oversight of the WCH Stability Program and coordinate non-PET SOP revisions and approvals of cross-site SOPs.
• Strong collaboration with the US sites and to ensure consistent application of quality systems / processes across the site.
• Influence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration.
• Training and mentoring of other members of the Compliance organization and strong performance history of consistently meeting and exceeding expectations.

Essential for the role:

• Bachelors degree required
• Excellent oral and written communication skills and strong ability and motivation to learn
• Five (5) years of pharmaceutical industry experience with 3 years in QA.

• Knowledge of pharmaceutical compliance, industry best practices, and a strong familiarity with production operations.
• Good decision making skills and judgment skills.
• Knowledge of regulatory/cGMP requirements and the ability to coach and mentor peers.

Desirable for the role:

• Bachelor’s degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering.
• 7+ years in quality assurance/regulatory compliance in the pharmaceutical industry.
• Prior experience with regulatory inspections.
• ASQ certifications (e.g. CQA, CQE).
• Member of pharmaceutical trade associations such as ISPE, PDA, etc.

Why AstraZeneca?

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. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. 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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Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.