Global Head of Quality Operations

2 weeks ago

Dublin, Dublin City, Ireland Quality Analytics Full time

The Head of Quality Operations is the Quality Business Partner for Alexion Operations, Information Technology (IT) and Product Development & Clinical Supply (PDCS). This role leads the strategy and execution for quality assurance and quality control at Alexion's Manufacturing Facilities and Contract Manufacturing Organizations (CMOs) worldwide. Strategies will include Alexion's support of the production of commercial products as well as products supporting the clinical pipeline. The Head of Quality Operations will ensure compliance at Alexion internal and external facilities meet and/or exceed all Alexion and global regulatory standards.

Principal Responsibilities

  • Ensure the manufacture of drug substance, drug product, finished product, medical devices and combination products are performed in a safe, compliant manner, meeting the regulatory requirements defined in relevant health authority submissions, cGxP and local Health and Safety requirements.
  • Provide strategic and tactical leadership to the Quality organization responsible for the manufacture of Alexion commercial and clinical products.
  • Recruits, retains, and develops highly competent and professional teams responsible for the management of Quality Operations to ensure the compliance of Alexion commercial and clinical products globally.
  • Collaborates with cross-functional project teams to support activities necessary for the management of 3rd party CMO's and furtherance of Alexion Clinical portfolio.
  • Ensures that Alexion sites have the facilities, equipment, and utilities appropriate to their needs. Works with the local site and quality management teams to ensure that infrastructure needs are identified, justified, and presented for budget consideration.
  • Ensures that there is an empowered, effective, and efficient quality organization in place and that it is staffed with competent personnel having the appropriate degree of experience and expertise.
  • Builds and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
  • Develop and maintain strong and effective relationships with partners including Internal Manufacturing Facilities, Commercial Operations, Process Development, Regulatory Affairs, Human Resources, Legal and Finance leadership to ensure corporate goals are met.
  • Maximize the utilization of quality resources to ensure compliant, cost-effective, and on-time supply of products.
  • Lead the Quality Operations Management Review for the Operations, IT, and PDCS leadership teams and ensure robust measurement and reporting tools are developed to enable accurate and timely reporting to senior management.

Qualifications

  • Demonstrated leadership skills in developing, motivating, and organizing high performing work groups in the biotechnology industry.
  • Demonstrated abilities in the operation, validation, and on-going compliance of cGMP biotechnology facilities.
  • Knowledge of regulatory requirements for clinical and commercial biopharmaceutical products.
  • Knowledge of mammalian cell culture.
  • Demonstrated project management and meeting management skills.
  • Ability to organize and assimilate data/information and prepare strategies from it.
  • Ability to see the big picture; to prepare contingency plans and future strategies; to be proactive; to initiate continuous improvement projects.
  • Understanding of the budgeting process for manufacturing operations.
  • Excellent communication skills-both upwards and downwards and outside the company. Ability to lead and communicate orally, in written documents, and in formal presentations is required.
  • The individual in this position is expected to represent Alexion Pharmaceutical interests, objectives, and policies in a professional and responsible manner.

Education

  • BS in engineering, science, or business; advanced degree MS, PhD, or MBA desired.
  • A minimum of 15-20 years' experience in leadership positions in biotechnology quality, manufacturing related operations is required, with multiple areas of expertise preferred.
  • Experience with licensed biopharmaceuticals products is required.
  • Extensive experience and excellent working relationships with Health Authorities or regulators including FDA, EMA and PDMA is required
  • Extensive experience in supporting clinical biopharmaceuticals is highly desired.
  • Experience in establishing and improving quality systems is required.
  • Ability to manage personnel at multiple sites and geographies with differing essential.

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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