Quality Assurance Leader for Early Phase Clinical Research

About The Role

Were seeking an experienced professional to help lead quality oversight for our early phase clinical research this role youll ensure site compliance with Good Clinical Practices (GCP) regulatory requirements and internal SOPs while fostering a culture of quality across cross-functional teams. Youll oversee an auditor team develop and maintain quality systems and partner with clinical operations to proactively identify and mitigate risks to impact drug development and patient outcomes. The Manager Quality Assurance is responsible for leading QA staff resources and assigned QA activities to ensure effective quality oversight timely execution and compliance with applicable internal procedures and external regulatory requirements. The role supports a risk-based quality approach by integrating quality data audit outcomes inspection findings compliance trends and operational input to guide QA priorities and continuous improvement. The Manager Quality Assurance also supports inspection readiness quality issue escalation staff development and the effective execution of QA programs within the assigned site function or business area.

Youll Do Here

• Lead and manage QA staff workload and priorities to ensure effective execution of QA activities.

• Provide coaching performance feedback and development support to team members.

• Support hiring onboarding training and ongoing staff development.

• Promote accountability consistent QA standards and professional conduct within the team.

• Oversee QA programs including audits inspections documentation review and quality system activities.

• Ensure QA activities are conducted in compliance with procedures regulatory requirements and timelines.

• Support audit planning and execution using a risk-based approach.

• Ensure appropriate follow-up and oversight of audit and inspection findings.

• Apply risk-based approaches to QA planning prioritization and issue escalation.

• Integrate quality data audit results inspection outcomes and trends to identify risks.

• Monitor quality indicators and escalate significant or recurring issues.

• Oversee or support quality system activities such as deviations investigations root cause analysis and CAPAs.

• Ensure quality issues are properly documented assessed and resolved.

• Support quality initiatives and continuous improvement activities.

• Recommend improvements to processes procedures and QA practices.

• Support preparation coordination and follow-up of sponsor audits and regulatory inspections.

• Participate in inspections as a QA representative as applicable.

• Review audit and inspection responses to ensure accuracy and compliance.

• Maintain effective relationships with internal stakeholders and external partners.

• Ensure QA activities comply with SOPs policies and applicable GxP requirements.

• Maintain awareness of relevant regulatory requirements and industry trends.

• Support development and maintenance of SOPs and controlled documents.

• Monitor and report QA metrics risks and performance indicators.

• Provide updates to QA leadership on key issues and initiatives.

• Communicate effectively with internal teams and external stakeholders.

• Support escalation of quality issues as needed.

What Youll Need to Succeed

• Bachelor degree or higher in Chemistry Biochemistry Biology

• Minimum of 5 of related experience

• At least 2 years (of the 5) related supervisory experience

• MS Word Excel Outlook and Power Point

• Ability to read and interpret technical documents and industry specific manuals.

• Ability to write advanced reports and correspondence.

• Ability to speak effectively before groups of customers or employees of the organization

• Experience in the pharmaceutical industry.

• Knowledge and understanding of the applicable Canadian US European and ICH pharmaceutical

• regulations and guidelines for phase I research studies (i.e. GCP GLP and GMP).

• Detail oriented.

• Project management and coordination skills.

• Ability to meet tight deadlines.

• Tactful reliable persuasive dependable consistent flexible.

• Excellent verbal and written communication skills.

• Well developed interpersonal skills are required.

• Personal/professional integrity and proven discretion in handling confidential information.

• Ability to develop strong trusting relationships in order to gain support and achieve results.

• Capable of managing multiple conflicting priorities.

• Must be self-directed motivated and have a willingness to take the initiative to identify and anticipate client needs and make recommendations for implementation.

• Relevant industry experience a plus.

What We Offer

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences Benefits Package Includes:

• Health/Dental/Vision Insurance Plans

• 401(k)/RRSP with Employer Match

• Paid Vacation and Holidays

• Paid Sick and Bereavement Leave

• Employee Assistance & Telehealth Programs

Altasciences Incentive Programs Include:

• Training & Development Programs

• Employee Referral Bonus Program

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