Sr. Quality Assurance Specialist

Sr. Quality Assurance Specialist

POSITION LOCATION: London, ON

POSITION TITLE: Sr. Quality Assurance Specialist (FT/Perm)

POSITION REPORTS TO: Director, Quality Assurance

DEPARTMENT/UNIT NAME: Quality Assurance

JOB SUMMARY:

The Senior Quality Assurance Specialist responsible for planning and execution of Quality Assurance deliverables while overseeing and evaluation the work performed by the department and providing mentoring to the Quality Assurance staff.  This role requires advanced knowledge and experience in clinical quality assurance, global clinical research regulations, CAP and CLIA laboratory standards and industry standards in the conduct of clinical trial operations with a strong understanding of clinical research ethics and privacy.

AREAS OF RESPONSIBILITY:

Quality Assurance Implementation

• Develop, implement and track compliance of QA plans {study, internal process and annual).
• Project manage department projects and deliverables to ensure work is of high quality, meets timeline commitments and is well communicated to other stakeholders
• Oversee the development of Quality System documents including policy, procedure, instruction, guidance, and form/template development in collaboration with departments and senior management
• Monitor, evaluate quality indicators, QA reports and audit responses
• Support study operational teams with resolution of escalated issues
• Identify quality GCP risks and work with leaders to design mitigation strategies
• Lead investigations, audits or QA related corporate initiatives and mentor other QA staff in the performance of these activities

Regulatory, Ethical Conduct, and Audit Monitoring

• Act as a senior representative of Quality at internal and external meetings.
• Support Sponsors, corporate and clinical operational teams with global quality, regulation, ethics and privacy inquiries.
• Remain knowledgeable and current on industry environment and regulatory legislation
• Mentor QA staff

 Expertise, Mentorship and Training

• Serve as a technical role model, motivator and mentor to the members of the quality team.
• Assist the Director with the development of departmental budget activities as the technical expert on audits and associated
• Develop and provide training both within the department and external to it.

QUALIFICATIONS:

Applicants must have a minimum of an undergraduate degree preferably in a Science and Life Science field along with 8+ years of relevant experience. The successful candidate will possess a strong background in process improvement including establishing/maintaining Standard Operating Procedures (SOPs). Experience and knowledge of Good Clinical Practice (GCP), computer system validation and CAP/ CLIA are an asset. Must have excellent verbal and written communication skills along with an advanced level of attention to detail. Must also demonstrate strong interpersonal relationship, collaboration skills working within cross-functional teams and a passion for Quality.  Successful candidates must exhibit enthusiasm, determination, and intuitiveness, and be organized and detail-oriented.

WORKING CONDITIONS:

 Office Based

*Accommodations for job applicants with disabilities are available upon request.

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