Director, Quality Risk Management Strategy GxP

Recruiter
Alexion Pharmaceuticals
Employment Type
Permanent
Salary
Not disclosed
Alexion Pharmaceuticals logo

Some opportunities happen only once in a lifetime – like a job where you have the chanceto 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 Director, Risk Management Strategy will play a key role in evolving Alexion’s Quality Risk Management Process / Active Risk Management Technology across the Alexion Rare Disease Unit. In this role, the Director will provide strategic direction for the Quality Risk Management group and engage with customers across the business to ensure their risk management needs are met. The Director will guide Alexion’s risk program evolutionensuring quality risks are understood, communicated across the business and actioned. The Director will also support key Quality Strategic Ventures projects that require sound risk management principles, such as due diligence assessments and asset integrations.

You will be responsible for:

Customer Engagement

  • Partner with business units to ensure consistency in risk management and adoption of risk-based thinking.
  • Assist with the identification of potential systemic gaps and develop and propose remediation plans for global and / or cross-functional implementation.
  • Present, explain, and defend risk metrics and procedures at Quality Management Review and other key stakeholder forums.
  • Represent Risk Management program to GxP Partners; faciltate discussions at Risk Councils, local risk workshops, and other risk evaluation settings.

Ensure Compliance in Areas of:

  • Ensure compliant risk management processes (per ICH and ISO guidelines) for Alexion business units delivering medicines and serving patients with rare disease including:
  • Risk Assessment, Risk Control, Risk Communication, and Risk Review
  • Ensure effective application of Risk Methodology and Tools including FMEA, FMECA, FTA, HACCP, HAZOP, PHA, Ranking and Filtering, and Statistical Methods

Risk Strategy & Program Management

  • Guide Alexion’s QRM program evolution alongside AstraZeneca (AZ) colleagues, coaching shared ways of working and best practices across Alexion Rare Disease Unit and the AZ network.
  • Assist the Business Process Owner with revising and updating the QRM SOP and Risk Management Tools as the business needs evolve.
  • Responsible for the effectiveness and ongoing evolution of Alexion’s Quality Risk Management Program and approaches through development of mitigation and improvement plans.
  • Represent Quality Risk Management function for health authority inspections, response preparation and remediation on QRM related topics.
  • Conduct analysis of risk assessments and rankings and develop risk analytics and reporting dashboards to support Management Reviews and inform decision making.
  • Responsible for maintenance of Alexion’s Global Quality Risk Register.
  • Apply proactive risk management principles to strategic projects such as due diligence assessments, asset integrations, and other complex iniatitives lead by Quality Strategic Ventures.
  • Ensure QRM tools are leveraged in cross-functional project and business scenarios.

You will need to have:

  • Proficiency in developing presentations to facilitate meaningful discussions, with clearly communicated analysis, findings, and impact.
  • Bachelor’s degree in business management, engineering, or scientific discipline.
  • 10+ years of experience leading and supporting risk management activities in a pharmaceutical, biotech, medical device, or related regulated industry under ICH Q9, ICH E6(R2), or ISO guidelines (ISO , ISO )
  • 3+ years experience working in a GxP regulated area outside of Quality, including laboratory settings, operations/manufacturing, research and development in preclinical or clinical studies, or distribution/supply chain.
  • Demonstrated ability to prioritize workloads through effective decision making
  • Ability to work collaboratively, raise issues in a productive way, and reach consensus in cross-functional settings, in remote work settings, across global cultures.
  • 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:

  • Advanced degree (Ph.D., MBA or Masters) a plus.
  • Experience working on company acquisitions, divestitures, asset or product transfers between entities.
  • Experience and knowledge in one or more of the GxP areas or therapeutic modalities (GLP, GCP, GMP, GDP, Medical Devices, Comination Products, Biologics, Small Molecules, Gene and Cell Therapy)

Alexionis 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. Furtherinformation about Alexion can be .

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 lackthereof, sex, sexualorientation, 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 aninteractive dialogue with Alexion regarding an accommodation, please contact . 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, clickhere.

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