Compliance Specialist/Sr. Compliance Specialist - Newark, DE - Global Operations
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 Compliance Specialist/Sr. Compliance Specialist in Newark, DE, you’ll play a pivotal role in channeling 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.
Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries we’re focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK
This position resides in the Compliance and Quality Systems organization and provides both tactical and strategic leadership for Compliance and Quality activities within operations or sites.
The Compliance Specialist is not necessarily performing all the major responsibilities of the role immediately. The incumbent may begin by specializing in one or more of these responsibilities whilst working to develop a solid knowledge of the process being supported and applicable cGMPs. Over time the incumbent will be expected to obtain the necessary training to become skilled in all major responsibilities of the role.
The core responsibilities of the role are as follows:
- Manage all Compliance programs and lead/execute required Compliance activities to ensure the site meets current GMP requirements of all local/global regulations and internal AZ Quality and Compliance policies.
- Provide oversight/process ownership for core Quality Systems including but not limited to: Complaints, Quality Events / Deviations, CAPA, Change Control, Product Reviews, Internal Audit Program, and other Quality Systems as needed to support the site.
- Drive continuous improvements 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.
Specifically this position focuses on: Change Control Management
- Serve as primary point of contact for Regulatory Agency communications. Lead the preparation, planning & logistics, inspection management, and response/follow-up for Customer and Lead the preparation, planning & logistics, inspection management, and 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.
- Lead/actively participate in site Quality Council and other Quality and Operations Forums.
- Design/Develop/Deliver site cGMP site Training Programs as needed.
- Review/Approve SOP changes.
- Lead projects or actively participate on teams related to Compliance, Quality Systems, and continuous improvement initiatives.
Quality Systems Processes Ownership:
Provide site-level process ownership for the following core Quality Systems:
- Product Quality Complaints
- Change Control
- Quality Deviations
- CAPA Management
- Internal Audit Program
- NDA Field Alert program/process
- Customer Quality Management (where the Newark site is acting as a 3rd party supplier of products)
- Site Master File
- Product Reviews
- Product Containment
- Quality Risk Management
- Implementation of revisions to global regulations / policies in the AZ Global Quality and Compliance Manual
The core principles of process ownership include, but are not limited to:
- Management of the quality system to ensure consistent application of the system and processes across site.
- Manage/own the procedures related to the Quality System and update as needed to ensure compliance.
- Manage accounts, system access, permissions for quality system applications, including periodic audit of accounts/users.
- Lead the site training program for the quality system.
- Collaborate with other sites to create standard quality systems requirements where possible.
- Collaborate with the global process owner (where applicable) to ensure compliance with global policies.
- Execute data queries/analyses and publish periodic trend reports.
- Provide routine reports as required for support of regulatory documents, inspections, or focus teams. Examples are: Product Reviews; Regulatory submissions; Complaint trend reporting, KPI and Compliance reports.
- Provide trend analyses as requested, and proactively identify and act on positive and negative system trends.
Senior Compliance Specialist
At this level the incumbent will be trained and demonstrate some level of understanding of all the major responsibilities of the role. The incumbent will also demonstrate a high level of proficiency in the primary processes the individual manages.
In addition to this the incumbent must have consistently demonstrated the following:
- Strong collaboration with the other regional and global sites to ensure consistent application of quality systems / processes across the site
- Self-motivated, demonstrates leadership, and works independently with minimal guidance from management.
- High level of proficiency in problem solving, creativity, independent thought, and sound judgment.
- 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
- Bachelor’s degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering is required.
- Excellent oral and written communication skills.
- Strong ability and motivation to learn.
- Ability to collaborate and participate in multi-disciplinary teams.
Sr. Compliance Specialist
In addition to the above requirements, the following additional requirements apply:
- Minimum of five (5) years experience in the pharmaceutical industry and/or FDA experience with at least three (3) years in Quality Assurance/Compliance.
- Strong knowledge of global regulatory and cGMP requirements, industry best-practices
- Strong familiarity with production operations.
- Strong leadership, project management, and technical writing.
- Strong interpersonal, communication, and influencing skills.
- Minimum of seven (7) years in QA/Regulatory Compliance in the pharmaceutical industry.
- Prior experience leading/managing regulatory inspections.
- Experience managing Quality Systems
- ASQ certifications (e.g. CQA, CQE, CQM).
- Active member of pharmaceutical trade associations such as ISPE, PDA, etc.
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 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.