Senior Manager, Quality Operations (external)

Senior Manager for Quality Operations

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 technical transfer processes at contract manufacturing organizations (CMOs). 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.

You will be responsible to:

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 tech transfer 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 organizations to both internal Alexion and country specific regulations.
• Building partnerships across the business to create a culture that demonstrates excellence in quality, compliance and continuous improvements.
• Providing quality and compliance guidance on all critical and major quality matters managed by Alexion/AZ.
• Trending and analyzing quality aspects of technical transfer activities to measure key performance indicators, identify areas for continuous process improvements and risk mitigation, and propose and lead team implementation of appropriate CAPA.
• Providing 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.
• Creating 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 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 organizations.
• Support contract manufacturing organization 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.

You will need to have:

• Minimum 10-15 years GMP related experience in biopharmaceutical / pharmaceuticals.
• Significant experience working with contract manufacturing organizations on New Product Introduction and Tech Transfer.
• Must have excellent communication skills, including excellent written, interpersonal, collaboration, and negotiation skills, with a team oriented approach.
• Enables effective goal setting, development, coaching and stretch assignments for own teams.
• Ability to provide project leadership and guide successful completion of Quality projects.
• Plans and drives delivery with an understanding of cross-functional interdependencies.
• Must have thorough knowledge of biopharmaceutical manufacturing, including testing and distribution processes and associated global regulatory GMP/GDP requirement.
• Experience providing QA oversight across end-to-end technical transfers for biologics—reviewing/approving transfer plans and protocols, ensuring CPPs/CQAs are aligned and compliant. Supporting engineering and PPQ runs including associated deviations, CAPA, and change controls.
• Actively learns about the industry, products, market and regulatory landscape. Can interpret implications on own area and guide teams around regulatory documentation, applications and review.
• Must have strong task management skills with the ability to prioritize, schedule, and control under tight deadlines. Creates actionable work plans for own areas, accounting for dependencies across different teams.

We would prefer for you to have:

• Experience leading teams.
• Extensive demonstrated pharmaceutical quality experience.
• 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.

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.