Senior Specialist, External Quality

31604
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.
This Is What You Will Do
The Senior Specialist for External Quality will be responsible for providing oversight of quality activities associated with small molecules for drug substance, drug product, finished product, and manufacturing processes. The Senior Specialist will provide Quality oversight to the Product Development and Clinical Supply (PDCS) at the New Haven site and CLO/CMO’s. The Senior Specialist contributes and supports the completion of milestones associated with specific projects and supports ongoing quality assurance responsibilities in support of: Contract Manufacturing oversight and quality systems including Change Control, Deviations and CAPA's. The Senior Specialist will be responsible for quality oversight of internal /external testing, stability, analytical technical transfer, GMP compliance and inspection readiness.
You Will Be Responsible For

• Reviewing and approval of stability reports, analytical development and verification reports and Lab investigation reports.
• Managing the timely completion of QMS records aligned to Global quality metrics ensuring compliance with the QMS, evaluating trends for LIRs and deviations and continuously improving quality performance.
• Supporting Quality Assurance to guide various projects and technical meetings, as needed
• Working closely to build relationships with contract manufacturers quality personnel
• Partnering with other Quality colleagues on significant product quality impact assessments, particularly for notifications to management, recalls, etc.
• Proactively identifying and communicating clinical product quality risks feeding into the Global Quality & PDSC Risk register ensuring they are proactively mitigated, actioned, and escalated to senior management
• Providing oversight of GMP systems completed by CMO's and External Supply Chain function related to Drug Substance, Drug Product and Finished Product.
• Managing the workload and prioritization of quality oversight to align with CMC product timelines.
• Working closely with internal cross-functional impacted areas, such as External Plant Operations, CMO Management, CMC/Regulatory Affairs and Technical Services to resolve open issues in a timely manner resulting from record reviews and deviation events
• Reviewing Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness
• Serving as Quality Assurance support and SME for Drug Substance, Drug Product and maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing, storage and shipping activities are compliant
• Documenting and reporting compliance issues to management
• Overseeing and implementing phase appropriate GMP compliance for method development through to method validation to support robust commercial testing programs
• Reviewing contractor documents i.e., Batch records, deviations and change controls to ensure that they comply with Alexion procedures and meet Alexion standards
• Acting as Quality team member responsible for review of technical documents, analytical method transfers and validation for Phase 1 to III clinical products
• Approving Alexion specific standard operating procedures and controlled documents issued by contract manufacturing organizations
• Reviewing and assessing deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending
• Providing oversight to continuous quality system improvements and support implementing improvements at CMO's in compliance, Preventive Maintenance, Deviation Management and Change Control Programs as they impact Alexion
• Member of the PDCS Quality team responsible for the quality oversight of analytical testing (internal & External) and stability programs.

You Will Need To Have

• Ability to operate efficiently in a complex matrix organization and international environment
• Ability to prioritize daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment
• Risk assessment and risk management
• Ability to monitor and report on assigned tasks, goals, and objectives.
• Excellent written and verbal communication and negotiating skills
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
• Bachelor’s degree required (scientific field)
• Strong mature leadership and interpersonal influencing skills
• Ability to exercise judgment with defined procedures and practices to determine appropriate action
• Ability to provide project leadership and guide successful completion of Quality projects

We Would Prefer For You To Have

• Experience working with contract manufacturing organizations.
• Preference given to candidates with Chemistry degree
• Must have knowledge of industry best practice and current regulatory expectations concerning drug substance, drug product and finished product manufacturing.
• Minimum of 5 years' GMP related experience in biopharmaceutical / pharmaceutical or related industry
• Minimum 5-8 years’ experience of drug substance/drug product manufacturing processes in a cGMP environment and technology transfers.

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
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 has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. All US-based employees must comply with Alexion's COVID-19 vaccination mandate. Alexion provides exceptions based on applicable state law as well as reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding a legally required exemption or accommodation, please contact [email protected]. Alexion participates in E-Verify.
As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, and much more.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.