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, Country Quality will be responsible for managing the implementation and execution of the Corporate Quality Management System (QMS) within Alexion Canada. The candidate will be the primary Quality contact and will have strong experience in GxP\xe2\x80\x99s, QMS and Health Canada GMP requirements as well as the ability to function independently and in a matrix environment.
You will be responsible for:

• In coordination with the Director, US and Canada Regulatory and Quality Affairs, Regulatory Affairs and related peers within the Global Quality organization, the Associate Director, Quality, will work to ensure the roll out and on-going compliance to Alexion\xe2\x80\x99s global quality and compliance systems, and associated procedures and standards at the site level.
• Ensure that Alexion Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with local GMP/GXP guidelines.
• Ensure Alexion is kept fully informed of new or emerging Health Canada GMP and regulation changes.
• Manage the review and implementation of Quality Improvement/remediation plans identified through Corporate as well as internal GMP/GXP audits.
• Provide Quality expertise and leadership, lead local/regional Quality activities.
• In collaboration with the Corporate Quality organization, weigh and communicate quality and compliance risks as appropriate.
• Monitor GMP/GXP compliance to regulations and Alexion\xe2\x80\x99s procedures and communicate CAPAs and action plans to Country Management and Corporate Quality.
• Partner with local, regional and global operational groups to foster a proactive approach to compliance.
• Act as primary responsible person overseeing all QA related tasks including lot release of products imported by Alexion in compliance with Health Canada GMP requirements.
• Coordinate with Supply Chain to prioritize lot release activities as per business needs.
• Act as lead for preparation, coordination and management of Health Canada GMP inspections.
• Ensure quality oversight and activities associated new product launches and indications.
• Ensuring that a quality management system (QMS) is implemented and maintained, in line with Corporate Quality and Health Canada GMP/GXP requirements, including but not limited to;
  • Deviation Management
  • Corrective Action Preventative Action (CAPA)
  • Complaint Management
  • Change Control Management
  • Documentation Management.
  • Training Management
  • Recall Management
  • Self-Inspection Management
  • Quality Risk Management
  • Quality Management Review
• Manage a small Quality team of professional(s) to ensure routine QMS and Quality activities are operating in compliance with Corporate and Health Canada requirements.
• Support other functions (e.g., Pharmacovigilance) as required by providing Quality input and identify risks to the QMS.
• Authorizing the return to saleable stock of any returned medicinal products.
• Ensure that adequate records are maintained.
• Ensure systems are in place for initial and continuous training for all personnel involved in GMP/GXP activities.
• Overseeing the qualification and approval of suppliers and customers.
• Approving and maintaining quality agreements with vendors relating to wholesale distribution and/or transportation of medicinal products.

You will need to have:

• Bachelor\'s Degree in physical /life science or pharmacy.
• 8 years+ of hands-on Quality Assurance / Compliance and management experience in pharmaceutical/ biotech industry.
• In-depth knowledge of Health Canada regulations and guidelines (EMA, FDA, PMDA experience would be an asset) pertaining to GMP/GXP required.
• Experience in coordinating and managing of Health Authority inspections.
• Strong leadership ability.
• Strong knowledge of pharmacovigilance AE reporting systems and regulations an asset.
• Exceptional communication and interpersonal skills.
• Ability to work globally in a matrix environment.
• Ability to influence senior management, peers and stakeholders .
• Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs.
• Ability to multi-task and prioritize work.
• Strong organizational ability.
• Demonstrable computer skill.
• Ability for occasional overnight travel as required.

We would prefer for you to have:

• Advanced degree preferable

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.