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
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