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Manager, QS and Compliance - Operations

Plats Coppell, Texas, USA Jobb-id R-064844 Datum inlagd 10/31/2019

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.

As a Quality Leader you will be in a key role in the development and deployment of the Quality policies, processes  and systems necessary to establish and maintain a robust Quality System that assures compliance with all applicable global regulations.  You will provide leadership to the Quality function to assure that all processes, procedures and products are in full compliance with all regulatory requirements and internal corporate standards.

Main Responsibilities:

Ethical conduct and compliance

  • Ensures compliance of self and others to internal and external regulations

Fiscal and financial control

  • Follows AZ’s financial policies, manages people resources to policy requirements and delivers budgets.

People management

  • Optimizes performance outcomes of direct reports and ensures individuals understand the contribution they make.

Leadership and engagement

  • Understands the big picture and connects individuals to it in a meaningful way. Leads across functions

Compliance

  • Is accountable for ensuring compliance is understood and maintained across own functional area, and across functions.
  • Accountable for initial and continuing training of department (OJT and GMP Training) and site personnel (GMP Training) is carried out and adapted according to need.

Continuous improvement

  • Strives to continuously improve the established ways of working
  • Lead the Development, implementation, and management of Quality Processes and Systems for Lokelma Supply sites including Internal Auditing, Change Control, Quality Investigations, Corrective and Preventive Action, Complaint Management, Management Review, Annual Reports, Product Recalls, etc.
  • Operate strategically and tactically within the operations environment to ensure practical and timely provision of Quality decision making.
  • Monitor quality performance metrics and coordinate Management Review activities for executive leadership on a monthly or quarterly basis as determined appropriate for respective metrics.
  • Write, edit, and review Policies, Standard Operating Procedures and various Quality related technical documents in order to define and continuously improve the Quality Management System in a highly collaborative environment.
  • Provide oversight and review of Quality Event investigations (Nonconformance / failure, deviation, OOS, CAPA,
  • FAR, Critical Events, Recalls etc.) and document using appropriate reporting methods and systems.
  • Represents the company to vendors, regulatory agents, auditors, executives, members of various industry associations, etc. in various settings both on and off site.

Minimum Requirements:

  • Bachelor’s degree in a science or engineering curriculum.
  • A minimum of ten years of experience as a Quality professional in the pharmaceutical manufacturing industry (finished drug product or Active Pharmaceutical Ingredients / complex chemical processing of excipients), in progressively more responsible management and leadership positions.
  • Advanced knowledge of cGMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies; experience in an aseptic environment advanced knowledge of regulatory agency interactions and compliance
  • Demonstrated management skills; ability to influence and engage direct and indirect reports and peers.
  • Strong written, oral, interpersonal, and presentation skills and the ability to effectively interface with all levels of management and staff.
  • Must be willing to address emergent factory quality and compliance issues by being available via telephone during off hours.

Preferred:

Graduate degree in engineering, science, or business  is desirable.

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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