Senior Compliance Specialist - West Chester, OH | Biospace
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Senior Compliance Specialist

AstraZeneca Pharmaceuticals LP

West Chester, OH
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location: West Chester,
United States
Job reference: R-008557

Posted date: Jun. 02, 2017

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Senior Compliance Specialist in West Chester, Ohio, you’ll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

As the Senior Compliance Specialist, you will reside in the Compliance and Quality Systems organization and provide strategic and tactical leadership for compliance activities within operations or sites. You will:

• Manage all compliance programs and lead/execute required compliance activities to
ensure the site meets current GMP requirements of local/global regulations and internal AZ quality and compliance policies.
• Drive continuous improvements efforts through monitoring/evaluation of site systems & processes against current compliance requirements and influencing key stakeholders on recommended compliance improvements.
Host/lead/manage inspections of site by External Customers, internal assessors, and regulatory authorities.
• At the Senior level the incumbent will have cross-trained and demonstrated strong knowledge and expertise in all of the major responsibilities and processes of the role. The incumbent will also demonstrate an expert level understanding of the primary processes the individual owns or is aligned with. The incumbent will act as execution lead/process owner for one or more processes. In addition to this the incumbent will be able to provide documented evidence of the following:

Essential Job Functions:
Compliance Leadership
• Serve as primary point of contact for Customer and Regulatory Agency communications.
• Lead the preparation, planning & logistics, inspection management, and management of formal response/follow-up for Customer and Regulatory Agency Inspections.
• Collaborate with/Influence key operations customers to drive the site Compliance
Improvement Program.
• Provide compliance expertise to the site, consulting with customers and helping to identify compliance gaps, recommending compliance improvements or solutions for the supply site.
• Core team participant on Issues Management Teams, driving resolution of complex
compliance issues.
• Author/Publish regular Compliance Reports to site and quality leaders.
• Lead/actively participate in site Quality Forums including: Quality Review Board, Quality Assessment, and Compliance meetings.
• Design/Develop/Deliver site cGMP site Training Programs as needed.
Compliance Processes
• Manage/lead the Internal Audit Program and drive corrective actions to completion.
• Manage the NDA Field Alert program/process.
• Manage Site Change Control noting applicable regulatory post approval impact
• Collaborate with GES in the Management of Supplier Performance, including
monitoring supplier performance, escalation of supplier performance issues, and driving issue resolution. Serve as primary point of contact/site Compliance representative and interface with GES Category Leads.
• Manage qualification of general Site Services Providers with GMP impact.
• Manage the preparation and maintenance of Quality Agreements (internal, external,
• customers).
• Review/Approve SOP changes for non-PET and cross-site SOPs.
• Lead the annual revision of the Site Master File (global supply sites).
• Evaluate OQ Announcements and revisions to the procedures/policies in the AZ Global Quality and Compliance Manual and OQ Announcements, and lead/drive compliance actions to ensure site level compliance with global requirements.
• Manage the preparation, review process, trend identification, and approval of Annual Product Reviews and Product Quality Reviews (for EU products). Drive corrective actions for any trends identified.
• Lead projects or actively participate on project teams related to compliance, quality systems, and continuous improvement initiatives across PETs, sites support groups, and cross-site groups.
• Manage/update SAP master data, where applicable.
• Lead/participate in risk assessment activities, where applicable.
• Cross-train to provide back-up support for other roles under Compliance and Quality
• A passionate champion of quality and compliance; maintain current knowledge of regulatory and industry trends and actively communicating these to colleagues.
• Leading/driving step change improvements to quality systems/ processes through cross- functional project teams.
• Expert level understanding of cGMPs and Quality Systems and competency to provide back-up coverage for the Site Compliance and Quality Systems Director as needed.
• Influencing and negotiation at all levels of the organization: globally and inside and outside of QA to deliver significant improvements in quality/compliance.
• Developing others by coaching/mentoring less experienced employees and interns.
• Supervision and oversight of activities of contractors and interns.
• Represent AstraZeneca interest in pharmaceuticals professional associations, discussions groups, etc.
• Strong performance history of consistently meeting and exceeding expectations

Essential Requirements:
• Bachelor’s degree
• Seven (7) years experience in the pharmaceutical industry and/or FDA experience with at least five years in Quality Assurance/Compliance.
• Demonstrated ability to work independently and collaboratively on multidisciplinary and multifunctional teams in the US and global.
• Expert knowledge of global regulatory and cGMP requirements, industry best-practices, and a strong familiarity with production operations.
• Ability to coach and mentor peers.

Desirable Background:
• Bachelor’s degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering
• Five (5) or more years in quality assurance/regulatory compliance - pharmaceutical industry.
• Prior experience with regulatory inspections.
• Experience in pharmaceutical data management systems.
• ASQ certification (e.g. CQA, CQE).

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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