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Compliance and Quality Systems Director (Pharma Manufacturing) - Operations

Местоположение Olde West Chester, Огайо, США Идентификатор вакансии R-066546 Дата публикации 11/22/2019

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.

In this role as Director of Compliance and Quality Systems, you will be in a senior level leadership position within the Quality organization.  The role has extensive responsibility for crafting and influencing the Compliance and Quality culture at the AZ supply and corporate sites.

Your role is critical in establishing an operating model that protects AZ’s reputation, product supply and license to operate.  It requires an individual that has extensive pharmaceutical operations experience including significant experience interacting with regulators.

This position will lead cGMP Compliance & Quality Systems at the supply site, maintain knowledge of, and implement, current cGMP regulations, AZ Quality & Compliance policies, and industry best practices for Quality Systems. You will ensure compliance with regulatory filings and regulatory agency reporting, and the implementation of compliance site initiatives and procedures.

You will be the principle contact for inspections by regulatory agencies, Global Operations Quality and external customers.

In this role you will have responsibility for managing a staff of Compliance and Quality professionals.  You will also be a member of the site Quality Leadership Team (QLT).

Main Responsibilities:

  • Leads efforts at the sites and influences the regional and global Quality organization to create policy, provide guidance and influence senior Leaders in the area of GMP compliance.
  • Accountable for being an influencing Leader with external regulators and key industry organizations such as ISPE, PDA and ASQ.
  • Provides the necessary leadership to create a vision, mission and road map for creating a culture of Quality and Compliance that is well integrated and supportive of end-to-end supply.
  • Provides Leadership and collaboration that engenders a culture of cross-site collaboration and fosters a very transparent and respectful approach with regulators in order to advance AZ’s influence and reputation.
  • Leads, coaches, mentors and develops a team of Quality and Compliance professionals.  Responsibilities include staffing, prioritization of work, performance management, and personnel development.
  • Leads site Compliance meetings and programs and ensures consistent execution of Quality Systems, and drives the efficiency and effectiveness of current compliance programs and quality systems across site PETs and services groups, as appropriate, including:

-Deviation Management and CAPA

-Product Quality Complaints

-Change Control

-Quality Risk Management

-GMP Documentation

-Regulatory Program Management (Field Alert, APR’s, Inspections, Compliance Improvement Plans, Site Master Plans etc)

-Product Quality Reviews

  • Supports continuous improvements efforts for computerized applications to key Quality System (e.g., Trackwise)
  • Responsible for the site’s QADC and Records Management departments.
  • Leads efforts to identify evolving regulatory and industry initiatives relating to compliance and quality systems and ensure proactive involvement of site. Actively participate in outside industry and professional associations, and influence these groups to adopt practices favorable to AZ.
  • A core team contributor in project teams and programs that are related to compliance, quality systems, and continuous improvement initiatives across the site. Responsible for identifying compliance gaps, and recommending compliance improvements for the supply site.
  • Supports the site in the investigation of issues requiring quality and compliance expertise.  Apply risk management.  Recommend and implement related compliance or quality system solutions.  Lead site Issue Management Teams (IMT) responsible for assessing
  • Oversight of compliance during the design, construction, start-up, validation, and retirement of equipment, process, utilities, facilities, computer systems, etc. across PETs.
  • Liaise with other AstraZeneca Site Quality groups to ensure standardization of compliance and quality system programs.  Represent the site on regional or global quality improvement teams.
  • Assist in preparing Quality department budget.
  • Other duties as assigned.

Minimum Requirements:

  • Bachelor’s degree in a science/technical field such as Pharmacy, Biology, Chemistry or Engineering.
  • Ten (10) years or more of experience in the pharmaceutical industry including management experience in a Quality or Compliance position.
  • Advanced knowledge of cGMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies.
  • Demonstrated ability to influence leaders in a matrix environment and the personal conviction to make courageous decisions to ensure patient safety and to protect company reputation

Preferred Background:

  • 7+ in supervisory/managerial roles within QA in the Pharmaceutical Industry.
  • Advanced degree, Masters or higher.
  • Multiple site or function experience.
  • Experience interacting with third parties (e.g., contract service providers) is preferred.  Strong auditing skills required with ASQC certification desirable.
  • Experience with device manufacturing regulations
  • Necessary characteristics include: being a self-starter, goal-oriented, attention to detail, team-oriented, ability to have positive interactions with other professionals without being critical, and ability to multi-task.

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.

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