Senior Manager, Quality Operations

at  Alexion PharmaceuticalsInc

EDUCATION/MINIMUM YEARS INDUSTRY EXPERIENCE:

• Minimum 10-15 years GMP related experience in biopharmaceutical / pharmaceuticals.
• Degree in Pharmaceutical Science or similar applicable discipline.
• Consideration will be given to other relevant experience and education in pharmaceutical biotech, or pharmaceutical organizations working in similar roles in Quality and/or Quality Control.
  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.

THIS IS WHAT YOU WILL DO:

The Senior Manager for Quality Operations will be responsible for leading and providing oversight of quality activities associated with drug substance/drug product and finished product manufacturing processes to contract manufacturing organizations. The Senior Manager drives the completion of milestones associated with specific projects and supports ongoing quality assurance responsibilities in support of Contract Manufacturing oversight, ensuring compliance with GMP in the supply of commercial and clinical product. Provide Quality service and guidance to various stakeholders. Execute strategies to control, and improve quality partnering with peers and influencing stakeholders to successfully embed a strong Quality culture. Identify, evaluate, and drive the remediation of quality risks and quality issues in collaboration with peers in Alexion’s portfolio.

This position will report to Director of Quality Operations. Duties included but not limited to:

• Managing Quality Assurance team responsible for providing oversight of quality activities associated with drug substance/drug product and finished product manufacturing processes associated with contract manufacturing organizations. Ensuring batches manufactured at contract organizations are released to cGMP and Alexion requirements.
• Ensuring compliance of all contract organisations to both internal Alexion and country specific regulations.
• Builds partnerships across the business to create a culture that demonstrates excellence in quality, compliance and continuous improvements.
• Provide quality and compliance guidance on all critical and major quality matters managed by Alexion/AZ.
• Ensuring timely review and approval for Annual Product Quality Review.
• Provide Quality oversight, input into quality documents e.g. QAGs, customer complaints as required.
• Author, review and approval of Quality Agreements (QAGs), ensuring Quality Agreements are maintained with all GxP vendors.
• Creates an environment for ‘right first time’ in focusing on principles of lean, visual management and building in efficiencies as necessary from a systematic and compliance perspective.
• Ability to apply lean approach to identify and tap avenues for improving the overall effectiveness of quality processes.
• Support Regulatory Inspections.
• Provide audit support for internal auditing program and supplier audits.
• Provide support to Regulatory for Regulatory submissions (IMPD, MAA)
• Serve as Quality Assurance support and SME for drug substance/drug product and finished product manufacturing maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing, storage and shipping activities are compliant.
• Acts as the Quality leader with the PDCS, Clinical Supply Quality teams, EM&O teams and other stakeholders to ensure on time delivery to the clinic and market.
• Providing oversight of GMP systems completed by CMO’s and External Supply Chain function related to Drug Product and Finished Product.
• Provides oversight to continuous quality system improvements and supports implementing improvements at CMO’s in compliance, Preventive Maintenance, Deviation Management and Change Control Programs as they impact Alexion.
• Works closely to build relationships with internal and external stakeholders.
• Works closely with internal cross-functional impacted areas, such as EM&O, Regulatory Affairs,Technical Services, Product Development/Clinical Supply to resolve open issues in a timely manner resulting from record reviews and deviation events.
• Oversees review of contractor documents i.e. Batch records, deviations and change controls to ensure that they comply with Alexion procedures and meet Alexion standards.
• Approve Alexion specific standard operating procedures and controlled documents issued by contract manufacturing organisations.
• Support contract manufacturing organisation audits, including pre-approval inspections.
• Ensure quality metrics pertaining to the process quality activities are maintained.
• Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
• Review Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
• Supports Quality Assurance to guide various projects and technical meetings, as needed. Uses data and insights for teams to be more responsive and support more effective decision making.
• Responsible for documenting and reporting compliance issues to management.
• Deputize for the Director, Quality Operations during holidays and occasion of absence as required.
• Any other duties as required by management