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Location:
West Chester, Ohio, United States
Job reference: R-048443
Posted date: Apr. 04, 2019
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At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

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.

Essential Job Functions:

  • 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.
  • 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.
  • Manage 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(e.g.,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.
  • 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.
  • Ability to work independently with minimal guidance from management.
  • 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.
  • Strong performance history of consistently meeting and exceeding expectations.

Minimum Requirements:

  • Bachelors degree
  • Excellent oral and written communication skills
  • 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.
  • Ability to coach and mentor peers.

Preferred Background:

  • 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.

Internal/External Contacts & Customers:

  • Site Compliance Specialists
  • Site Quality System Specialist
  • Site QC groups
  • GES QA
  • CMC Regulatory Affairs
  • GQO
  • FDA/Other Regulatory Agencies

Reporting Relationship:

Direct Reports: 0

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.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. 

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Senior Quality Systems Specialist - Global Operations
Quality

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