Job Description

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 – Governance, Risk and Control will lead the regulatory (e.g., GxP, Data Integrity, etc.) quality oversight program for Medical Affairs. This position will provide direction and oversight to the strategy, planning, management, and execution of all regulatory quality risk management and mitigation activities within Medical functions. This role will engage across all functions of Medical and the Company including global and affiliate personnel, Global Patient Safety, R&D Quality, and R&D Audit to effectively promote consistent and coordinated quality execution.
You will be responsible for:

• Development, implementation, and continual improvement of medical’s quality program as it pertains to regulatory quality, including risk assessment, governance, monitoring, reporting, oversight to audit/inspection readiness and remediation.
• Representing Medical Affairs in company regulatory quality forums (e.g., inspection preparation teams), and ensure cohesive inclusion of Medical with related Company functions and processes (e.g., Global Patient Safety, Regulatory, R&D Quality).
• Creating awareness and buy-in at all functions and levels of Medical on regulatory process and quality management concepts, best practices, and strategic relevance.
• Identifying opportunities for collaboration and foster communication within and outside of Medical to enable alignment on quality initiatives at the global and local levels and across functions.
• Providing guidance and collaborate with Process Owners and Subject Matter Experts in the development and maintenance of regulatory quality related processes and relevant risk management initiatives.
• Ensuring, in coordination with related stakeholders, robust GxP and regulatory quality training for appropriate medical functions.
• Engaging as a leader on Medical Affairs Governance, Risk and Controls initiatives, including Annual Risk Assessment.
• Leading strategy and execution of regulatory quality monitoring across Medical Affairs, on a risk-based methodology to be developed, to ensure adherence to quality expectations.
• Implementing and managing tools to track and report key quality metrics.
• Overseeing issue management including, root cause analysis, resolution design, timelines of implementation, effectiveness check, etc., and determine whether to escalate to R&D Quality.
• Communicating and influence at all levels of the organization.

You will need to have:

• 10 + years’ experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences and a minimum of 4 years’ experience working in a quality role or quality systems.
• Bachelors and PharmD, MD, PhD, NP, MS in Life Sciences or similar.
• Knowledge of Post-Marketing and Clinical Trial regulations and direct experience with GCP, GVP or GMP regulations.
• Strong management skills, and ability to effectively lead and collaborate with business functions.
• Demonstrated problem solving, decision-making, and conflict resolution skills.
• Drive a culture of agility by leading the way in optimizing processes and implementing pragmatic solutions.
• Foster strong alignment, collaboration and information sharing with cross-functional partners and make use of knowledge, expertise as well as data available within the team.
• Showcase high level of maturity to work autonomously and make sound judgement calls in environment of ambiguity.
• Be inclusive and encourage teamwork and mutual trust and respect for all team members.
• Exhibit flexibility with a sense of urgency to ensure balancing of competing demands (supporting many stakeholders).
• Practice consistent ownership and accountability attributes (“self-starter” and doer).
• 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:

• Familiarity with Medical Affairs
• MBA
• Project Management certificate

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 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.
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.