Compliance Specialist (Specialist / Senior Specialist / Principal Specialist) - R-202492-3919

at AstraZeneca Pharmaceuticals LP (AZPLP) in Newark, Delaware, United States

Job Description

Essential Requirements:

Minimum of 0 - 5 years relevant experience in GMP, Quality, and/or Compliance or equivalent

Preferred Experience:

Bachelors degree in Science or Technical degree or equivalent

The core responsibilities of the role are as follows:

• Handle all Compliance programs and lead/implement 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 collaborators on recommended Compliance improvements.

• Host/lead/handle inspections of site by External Customers, internal assessors, and Regulatory authorities.

This is a multi-career level role. The Job Responsibilities summarized above, and described in more detail below and represent the full scope of the role. The performance expectations at the different career levels are also described.

In addition to the general description of the parent profile role for this job function, the following summarize key result areas, specific accountabilities and / or tasks, etc. associated with this job title:

Compliance Leadership

• Serve as primary point of contact for Regulatory Agency communications.

• 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, coordinating 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.

• Lead procedures related to the Quality System and update as needed to ensure compliance.

• Handle 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

• Implement 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, critical metric and Compliance reports.

• Provide trend analyses as requested, and proactively identify and act on positive and negative system trends.

Career Level Descriptions: The Job Responsibilities provided above represent the full scope of the role. The descriptions below indicate the performance expectations at the different career levels.

Compliance Specialist: At this level the incumbent 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.

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 leads. In addition to this the incumbent must have consistently demonstrated the following: Collaboration with the other regional and global sites to ensure consistent application of quality systems / processes across the site o Self-motivated, demonstrates leadership, and works independently with minimal guidance from management. o High level of proficiency in problem solving, creativity, independent thought, and sound judgment. o Influence in team and project meetings, advising project teams. Training and mentoring of other members of the Compliance organization. o Strong performance history of consistently going above and beyond.

Principal Compliance Specialist: At this level the incumbent will have cross-trained and demonstrated strong knowledge and expertise in all major responsibilities and processes of the role. The incumbent will also demonstrate an authority level of proficiency in 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 must have consistently demonstrated the following: A hardworking champion of quality and compliance; maintaining current knowledge of regulatory and industry trends and actively communicating these to colleagues.

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.
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Job Posting: 1279112

Posted On: Jun 27, 2024

Updated On: Jun 28, 2024

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