Senior Director Quality Operations

Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
Position Summary
As a member of the Alexion Quality Operations Leadership Team, the Senior Director Quality Operations owns the Quality oversight of Alexion's PDCS (Product Development Clinical supply) operations!
As the Quality business partner to PDCS, will provide Quality oversight for PDCS (Analytical Sciences, Clinical pack and Device Development) in compliance with GMP (good manufacturing practices) and registered specifications. Additionally this role with provide leadership for the PDCS Quality, Clinical PQ L and Device Lifecycle Quality teams partnering with AO (Alexion Operations) through the lifecycle of the product from Phase III into commercial.
The operating framework of the role is centered on risk management and the compliant execution of day to day Quality Operations in compliance with current Good Manufacturing Practices and regulatory requirements.
This role acts as the Quality Business Partner for JSC (joint steering committee meetings) with Device and PDCS CLO partners and internal PDCS leadership team meetings, and is integral to the clinical / commercial product and device lifecycle management.
The incumbent will be responsible for building capability and skills within the Quality Team for combination products, biologics, synthetic and gene therapy modalities. This position will involve managing a team of direct reports, with a focus on developing their capabilities and skills, while encouraging a culture of risk-based, data-driven, lean, and innovative thinking!
Job Duties & Responsibilities

• Lead the quality strategy for PDCS (Product development clinical supply) clinical manufacturing quality partnering with AZ partners and external manufacturing.
• Quality representative on the PDCS Leadership team assuring appropriate quality oversight, device stage gate reviews, and delivery of time delivery of safe and compliant product.
• Implement tiered governance with E2E visibility of Quality management.
• Leads the quality partnership with external partners, integrations and AZ partners to ensure responsibilities as MAH are maintained, QAGs are in compliance and NPI activities are managed within the organisation.
• Ensure that all aspects of the handling, manufacturing and distribution of biologic and non-biologic drugs are in compliance with the Alexion's quality management system, the effective Quality Agreement and meets relevant cGMP regulatory requirements.
• Establish a lean digital governance for end to end QA release of commercial and clinical product; driving lean initiatives within the organisation aligned to AO strategic pillars.
• Drive quality compliance and performance metrics partners applying risk management; integrating metrics into AO tiered governance.
• Lead the inspection readiness programs with PDCS & AOQLT for Health Authority inspections and Alexion inspections.

Essential Qualifications

• Degree in science, engineering, or equivalent required. Advanced degree a plus.

Preferred Qualifications

• A minimum of 15 years proven experience in the Biopharmaceutical manufacturing industry. Min of five (5) years in a leadership role.
• Experience with management of contract manufacturing organizations is required.
• Experience of manufacturing processes for biopharmaceutical products is needed.
• Experience in new product introduction and technical transfer of biologic and non-biologic drugs.
• In depth knowledge of current regulatory requirements for cGMP operations.
• Direct experience of GMP audit management within the pharmaceutical industry is critical, and will include exposure to FDA, EMA or other authorities of similar standing.
• Demonstrated success in quality management and the resolution of technical challenges, which requires significant appropriate experience
• Experience negotiating contracts and/or Quality Agreements with partners required.
• Leadership skills in collaborating with the team to drive a process and governance, execute and track Quality and performance metrics.
• High level technical skills including quality risk management, auditing and pharmaceutical manufacturing and regulatory inspection management. Technical writing skills required.
• Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
• The individual in this position is encouraged to represent Alexion interests, objectives and policies in a responsible and professional manner.

Expectation of working in the office 3 days a week: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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.
Date Posted
23-Oct-2023
Closing Date
07-Jan-2024
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.