Associate Director, Investigations

Company: Alexion
Location: New Haven
Posted on: January 21, 2023

Job Description:

Career Opportunities: Associate Director, Investigations (30354) Requisition ID -30354 -- -Posted -01/15/2023 -- - Country (Multi Selection) (1) -- - City (Multi Selection) (1) -- -Quality 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 Associate Director, Investigations has a global focus within Global Operations and supports the implementation, continuous improvement, and expansion of device requirements (Clinical and Commercial) related to the Complaint Management Program.The Associate Director, Investigations -will assist in the design, implementation, and -maintenance -of the following processes: Global Complaint Management, Regulatory Reporting (Medical Device Reporting (US and EUMDR)), Country Quality Support, Product Security Investigations, and Complaint Trending for Global Operations.You will be responsible for:

• Implementation and -maintenance -of Global procedures/ processes associated with but not limited to complaint management, complaint investigations, regulatory reporting (US MDR, EU MDR, EU defective Product reporting), product security investigations, and monthly/quarterly complaint trending
• Providing daily guidance and direction to the complaints team related to the processing and resolution of incoming product complaints
• Ensuring timely closure of quality records in compliance with established procedures
• Leading periodic reviews of Quality System KPIs and other metrics to identify opportunities for improvement, and mitigate compliance risks
• Preparing the Quality Management Review data review metrics
• Trending and Data analytics for the Monthly Global Product Complaint Trend Report
• In collaboration with the Training group, develop and deliver training programs for Global Operations for the above activities
• Approver of the Global Market Activity Chapter for the Annual Product Quality Review of AstraZeneca Alexion Rare Disease Unit products
• Quality partner for complaint and investigation requirements of Alexion clinical trials
• Support audits and inspections as the Subject Matter Expert (SME) for the complaint management program, as appropriate
• Other duties as assignedYou will need to have:
  • Minimum of 7-10 years of experience in pharmaceuticals/ biopharmaceuticals or related industry with a concentration in Quality Operations/ Systems, investigation techniques, root cause analysis, and risk assessment
  • Bachelor's degree in Scientific or engineering discipline
  • Knowledge of applicable international GXP regulations and standards for Medical Devices
  • A strong internal and external customer focus and ability to prioritize and adapt to business needs are required
  • Demonstrated project management skills, experience leading and participating on cross-functional teams, problem-solving and decision making
  • Strong leadership, negotiation, collaboration, and influence skills in a matrix organization -
  • 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.
  • Ability to travel up to 15%We would prefer for you to have:
    • Global level experience
    • Clinical Trial experience 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 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, 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 .

Keywords: Alexion, New Haven , Associate Director, Investigations, Executive , New Haven, Connecticut