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Quality Assurance Specialist

3 months ago

Mississauga, Ontario, Canada Regeneron Pharmaceuticals, Inc Full time

Responsible for execution of quality review, approval and management of GMP Activities including Batch Records and associated documents and processes (internal and/or external deviations, change controls) for importation and distribution of biological drugs in the Canadian Market.

Responsible for ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

Collaborates across local and global QA teams to help provide support and drive teams to the most compliant, quality outcomes.

Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., Represents the IOPS organization on behalf of QA with external partners and suppliers to communicate IOPS QA policy and procedures; liaise with external partners and provide input on regulatory communications.

Provides QA direction for cross-functional teams. Can serve as an escalation point when additional escalation within Quality and the business is required.
Define and implement quality standards, systems, and metrics for maintaining regulatory compliance for operations.
Tracks relevant quality system metrics including deviations, corrective actions, change management and controlled document workflows.

Deputy RP, responsible for QA operations including creation, review and approval of the following types of documents, relating to area functions:

  • Change Controls
  • Complaints
  • Performs compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.
Reviews customer requirements and implements required processes, as needed, to meet customer expectations regarding Quality.
Participates in regulatory and customer audits.
Experience with management of importation of Medical Devices in the Canadian market.
Possesses a high level of expertise within QA Operations.
Good process management skills to accurately scope out / support projects
To be considered for this role you must hold a BSc in life sciences discipline or related field (chemistry, biology, or pharmacy preferred) with 8+ years' experience in a pharmaceutical/biologics environment desired or equivalent combination of education and experience

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency.