Patient Safety Compliance Management Director at AstraZeneca

Posted in Other 16 days ago.

Location: Wilmington, Illinois





Job Description:


Job Title: Patient Safety Compliance Management Director





Location: Onsite with flexibility in Wilmington, DE





Job Capsule:




This role provides technical leadership and direction in area of patient safety and pharmacovigilance (PV) quality and compliance. In addition, this role requires supervision of the US Patient Safety (PS) Compliance Management team on a variety of PV activities of multidimensional scope and complexity. The role leads the team to establish and implement quality and compliance Strategy and Quality Standard among cross-functional collaborators within US PS and US Marketing as well as across Global PS functions including monitoring, analysis, interpretation correction, prevention and reporting of operational quality issues and risks from all area of PS to ensure US PS inspection readiness at all times and to mitigate any risk to the business and support our license to operate. The successful candidate will also lead US GxP country related quality activities.




Typical Accountabilities:




  • Leads the US PS Compliance Management (CM) team by providing oversight, leadership, strategic direction and expertise to team

  • Responsible for driving a successful function within the US PS CM team by:

Ensuring effective allocation of resources by analyzing and building solutions according to business priorities and objectives Ensuring effective performance development including metrics, development of staff, recognition and rewards with accountability for the professional development of the US PS CM team Drives the development of PV skills, tools and efficient processes to increase the capabilities supporting US PS strategies and AZ's development projects and marketed products Attracts, recruits, deploys, leads, develops and retains staff with the aim of providing the right skills and expertise for the business areas and other PS functions required to deliver on objectives



Additional Accountabilities Include:



  • Ensures and monitors team compliance and compliance of third parties by positively reinforcing the AZ Code of Conduct and all relevant AZ policies and standards; also by fostering an open environment where employees are comfortable raising questions and finally, immediately addressing and reporting instances of non-compliance

  • Accountable for the oversight, lifecycle management, strategy, planning and development of the CM team that are aligned to global PS and US Medical strategies

  • As part of the leadership for the US PS CM team, reporting of operational quality issues and risks is required as well as follow up on audits and inspection findings

  • Establishes and maintains PV performance activities with critical metrics and compliance processes as needed

  • Leads activities to ensure state of inspection readiness and provision of PV expert input and support for GxP audits

  • Systematically captures, consolidates and communicates regularly with regulatory authority and industry intelligence for continuous improvement activities required to ensure license to operate within regulatory compliance guidelines

  • Establish, formalize and maintain an inspection network in support of the US businesses in the practical management of inspections using a risk-based framework, ensuring close and effective links with the QA function within region, Regulatory Affairs, Global PS and the EU leader for PV

  • Management oversight to agreed targets and provides expert, strategic regulatory or PV input and guidance on cross-functional teams

  • Ensures effective internal collaboration with key Global PS cross functional business units to drive strategy, development and continuous improvement of regional PV activities

  • Responsible for end to end lifecycle management of Safety Data Exchange Agreements (SDEA) and PV Agreements (PVA) with commercial development partners and supporting related business processes, standards and systems

  • Actively supports audits, inspections and regulatory inquiries as well as resolution of CAPAs

  • Raises issues as appropriate utilizing governance models and standard communication plans; participates in effective governance of global/regional/alliance partnership models as appropriate

  • Actively seeks innovative ways of working to drive improved performance and bring new solutions to customers and partners

  • Sees opportunities to adapt US PS networks/processes/compliance activities to strengthen and innovate key processes crucial to deliver effective high quality results from US PS

  • Retains a US perspective of the business needs for accurate high quality performance, resourcing and strategic plans in a cost effective manner while maintaining regulatory and internal compliance

  • Delivers high quality and timely PS input from the US to global in support of PS key priorities

  • As GxP Us Quality Lead, responsible for ensuring the effective operational implementation of the QMS across all GxP functions in the US





Required Education, Skills and Experience:




  • Minimal of BS degree in biosciences or related field of study

  • A minimum of 5 year PV and or Clinical Development experience within industry

  • Five years+ experience in a PV department including in-depth knowledge of PV practices including a comprehensive understanding of FDA and other Health Authority and ICH regulatory requirements and obligations

  • Demonstrated experience developing and driving PV activities in support of clinical development programs, product approvals, licensing agreements, acquisitions and divestments

  • Fluent in the English language with excellent expressive and receptive presentation skills as well as clearly written communications



Preferred Education, Skills and Experience:




  • Advanced degree within a related bioscience field

  • Professional Certification (PM, Lean Six Sigma, ASQ Certified (CQA), ASQ Certified Manager of Quality or SQA Registered Quality Assurance Professional

  • Three years of PV related QA auditing experience

  • Strong Project Management expertise





AstraZeneca - An Employer of Choice




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 offer a generous Total Reward program including a market driven base salary, cash bonus and long term incentive. We also provide a paid time off program and a comprehensive benefits package! If you can create a culture of fearless leadership, innovation and collaboration, please apply today!


AstraZeneca is an equal opportunity employer. AstraZeneca will consider all applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or parental 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 or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.


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.


AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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