Alexion Pharmaceuticals QA Manager, External Quality in New Haven, United States
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 position can be based from any of the following AstraZeneca/ Alexion locations; Wilmington, DE, Boston, MA, New Haven, CT, and may require up to 25% travel. *Boston, MA and New Haven, CT are preferred locations.
This is what you will do:
The Manager for QA External Manufacturing will be responsible for providing oversight of quality activities associated with drug substance, drug product, devices, and finished product manufacturing processes at contract manufacturing organizations. The Manager 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 Manager performs all responsibilities in accordance with company policies, procedures, and regulations.
You will be responsible for:
Serve as Quality Assurance support and SME for Drug Substance, Drug Product manufacturing maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing, storage, and shipping activities are compliant
Providing oversight of GMP systems completed by CMO's and External Supply Chain function related to Drug Substance, Drug Product, Devices 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 contract manufacturers' quality personnel. Support contract manufacturing organization audits, including pre-approval inspections.
Works closely with internal cross-functional impacted areas, such as Global Clinical Supply, CMO Management, CMC/Regulatory Affairs, and Technical Services to resolve open issues in a timely manner resulting from record reviews and deviation events
Responsible for reviewing contractor documents i.e. protocols, batch records, deviations, and change controls to ensure that they comply with Alexion procedures and meet Alexion standards). 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
Provide quality metrics pertaining to the process quality activities
You will need to have:
A minimum of 10 years relevant experience in the Biopharmaceutical manufacturing industry, with in-depth knowledge of current regulatory requirements for cGMP operations.
Experience with the management of contract manufacturing organizations is essential.
Experience in manufacturing processes for biopharmaceutical products is essential. Experience in new product introduction and technical transfer of biologic and non-biologic drugs essential.
Demonstrated success in quality management and the resolution of technical challenges, which requires significant appropriate experience.
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 expected to represent Alexion interests, objectives, and policies in a responsible and professional manner.
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.
We would prefer for you to have:
5+ years of commercial, operations, or project management experience within the biopharma industry with at least 3 years of managing complex projects
Bachelor’s degree, MBA, or equivalent level of experience
Understanding and adherence to PMI’s or similar Project Management methodologies
Business process mapping experience preferred
Excellent written and verbal skills and strong interpersonal skills
High level of proficiency in MS Office software including Word, Excel, Outlook, Visio, and PowerPoint
Mastery of Microsoft Project; knowledge of MS Project Server
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, parental 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.
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, relocation assistance 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 (https://careers.astrazeneca.com/) .