Medical Affairs Governance, Risk and Control

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 Alexion Global 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 Global Medical Affairs.  This role will engage across functions of Medical and the Company including Global Patient Safety, R&D Quality, and R&D Audit to effectively promote consistent and coordinated quality execution.

Responsibilities will include:

• Development, implementation, and continual improvement of Global Medical Affairs’ quality program as it pertains to regulatory quality, including risk assessment, governance, monitoring, reporting, oversight to audit/inspection readiness and remediation.

• Represent Global 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).

• Create awareness and buy-in at all functions and levels of Global Medical Affairs on regulatory process and quality management concepts, best practices, and strategic relevance.

• Identify opportunities for collaboration and foster communication within and outside of Global Medical Affairs to enable alignment on quality initiatives at the global and local levels and across functions.

• Provide guidance and collaboration with Process Owners and Subject Matter Experts in the development and maintenance of regulatory quality related processes and relevant risk management initiatives.

• Ensure, in coordination with related stakeholders, robust GxP and regulatory quality training for appropriate Global Medical Affairs roles.

• Engage as a leader on Global Medical Affairs Governance, Risk and Controls initiatives, including Annual Risk Assessment.

• Lead strategy and execution of regulatory quality monitoring across Global Medical Affairs, using risk-based methodology, to ensure adherence to quality expectations.

• Implement and manage tools to track and report key quality metrics.

• Oversee issue management including, root cause analysis, resolution design, timelines of implementation, effectiveness check, etc., and determine whether to escalate to R&D Quality.

• Communicate and influence at all levels of the organization.

You will need to have:

• Knowledge of Post-Marketing and Clinical Trial regulations and direct experience with GCP or GVP 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).

Qualifications and Education:

• 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. 

We would prefer for you to have:

• Familiarity with Medical Affairs

• MBA

• Project Management

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AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs.  In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).  Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.