Job Vacancy Associate Director, Strategic Advice R&D Quality Excellence Alexion Pharmaceuticals
Job title: Associate Director, Strategic Advice R&D Quality Excellence
Company: Alexion Pharmaceuticals
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:
As part of the R&D Quality Excellence Team you will drive Quality Culture with R&D stakeholders, through learning, embedding a quality mindset, and executing on continuous improvement opportunities. You will be responsible for managing business relationships with defined stakeholder groups and senior leaders in R&D and for the strategic development and delivery of a GXP risk based robust quality management activities for these stakeholders. Additionally, the job holder is responsible for delivery of proactive end-to-end GXP inspection support and management.
You will be responsible for:
Business Partnering
- Supports strategic direction on quality and compliance through engagement with defined stakeholder groups
- Provides responsive and proactive quality and compliance advice to stakeholder groups, effectively influencing assigned area by being relevant GxP expert
- Provides effective compliance reporting to senior management and supports strategic QA governance forums
- Supports quality and compliance risk management for stakeholder groups
- Supports Due Diligence activities as assigned.
Inspection
- Provides QA support for regulatory GxP inspections
- Supports end-to-end submission-related regulatory inspection strategy
CAPA
- Supports investigation of critical quality issues and ensures timely reporting of issues to relevant authorities
- Supports oversight significant CAPAs for clinical activities in R&D
General Accountabilities
- Ensures own tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelines
- Promotes a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits
- Communicates effectively with QA colleagues and business stakeholders
- Maintains knowledge of relevant industry information affecting quality and compliance arena
- Leads training for colleagues and business stakeholders as required.
- Involved in and may lead the development and/or revision of QA processes, projects and tools
- Coaches and mentors QA colleagues
- Provides general support related to regulatory authority inspections as and when required
You will need to have:
- Bachelor’s or Higher Degree in life sciences or similar scientific subject
- Significant experience in pharmaceuticals, 8+ years experience in the R&D quality assurance area
- Strong collaborative, influencing and interpersonal skills – curious to understand business environment
- Ability to maintain and create professional networks with stakeholders
- Experience in managing regulatory health authority GxP Inspections
- High attention to detail and accuracy
- High ethical standards, trustworthy, operating with absolute discretion
- Effective leadership skills
- Excellent communication skills; fluent oral and written English
- 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 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:
- Good analytical, problem-solving and negotiation skills
- Experience in working in a global role
- Cultural Awareness and Positive attitude in managing change
- Project Management experience
- Audit expertise
- Quality Management
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: .
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 [email protected]. 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 .
Expected salary:
Location: Boston, MA
Job date: Wed, 17 Aug 2022 22:56:01 GMT
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