Pharma QA Leader & Client Compliance Manager

Cencora; United States; Remote; USD 85.000 - 113.000; Vollzeit

Benefits dieser Stelle

Medical and dental coverage

Training & development

Zusammenfassung

Cencora, through Innomar Strategies, seeks a Manager, Quality Assurance (Consulting) to lead a Sr. QA Specialists team and support complex client quality deliverables in the Canadian market.

The role combines hands-on quality work with leadership, risk-based decisions, and proactive client engagement to ensure Health Canada compliance and robust GMP systems. You will mentor staff, manage audits, and drive continuous improvement across documentation, CAPAs, change controls, and training.

Qualifikationen

• Bachelor’s degree in a pharmaceutical, scientific or healthcare‑related field.
• 10+ years of Quality Assurance experience in a regulated pharmaceutical or healthcare environment.
• Minimum 3 years of people management or supervisory experience.
• Demonstrated experience with Health Canada requirements, GMP compliance, drug importation and Drug Establishment Licences.
• Experience conducting vendor audits and hosting or co‑hosting client, third‑party or regulatory audits is considered an asset.
• Experience working as a consultant is considered an asset.
• Experience with natural health products is considered an asset.

Aufgaben

• Lead and assign the day-to-day work of Sr. QA Specialists, balancing client commitments, compliance risk, business needs and established timelines.
• Provide clear direction, coaching, mentoring, training and cross-training to strengthen team capability, accountability, consistency and readiness for changing priorities.
• Remain hands-on in day-to-day quality activities and take ownership of complex or high-impact assignments, identifying issues early, making timely decisions within authority and escalating appropriately.
• Maintain importer Drug Establishment Licences and manage the approval process for foreign sites supporting multiple clients.
• Ensure compliance activities associated with the importation of drugs, medical devices and natural health products are performed in accordance with applicable Health Canada regulations and guidance.
• Perform or oversee the release of commercial drug products and/or clinical trial supplies to the Canadian market for Innomar or clients, as required.
• Maintain and review internal and client quality documentation, including SOPs, annual product quality reviews, stability reports, qualification and validation protocols and reports, artwork and temperature studies.
• Ensure deviations, corrective and preventive actions, product quality complaints, change controls and associated trend analyses are completed in a compliant, thorough and timely manner.
• Provide expert consultation to clients on quality matters by assessing risks, evaluating potential impacts, and recommending practical, compliant, and sustainable solutions to support informed decision‑making and business success.
• Actively contribute to the development, maintenance and continual improvement of GMP quality systems, including addressing deficiencies or inconsistencies when identified.
• Advise other departments on Quality Assurance requirements, risks and strategies.
• Support or lead internal, client, third‑party and regulatory audits or inspections, including serving as lead auditor or audit host when required.
• Support recall and mock recall activities, as required.
• Build and maintain positive, productive relationships with internal stakeholders, current and prospective clients, foreign sites and other external partners.
• Participate actively in client meetings and presentations, communicate Quality positions clearly and respond confidently to questions while remaining collaborative and solutions‑focused.
• Demonstrate initiative by volunteering for new responsibilities and adapting quickly to changing priorities, emerging issues and unfamiliar situations.
• Manage multiple projects efficiently and accurately, with strong follow‑through and dependable completion within established timeframes.
• Provide subject matter expertise through the delivery of training, presentations, and seminars to internal teams, clients, and external organizations, fostering awareness, capability development, and compliance excellence.
• Complete or support invoice reconciliation and quotation activities, as assigned.
• Understand and comply with company confidentiality and privacy requirements.
• Perform other duties and tasks assigned by Senior QA Management.

Kenntnisse

Regulatory knowledge

Leadership

Ownership

Decision making

Continuous improvement

Project execution

Risk-based problem solving

Client engagement

Digital proficiency

Collaboration

Ausbildung

Bachelor's degree in pharmaceutical/science field

Tools

Microsoft Word

Microsoft Excel

AI tools familiarity

Jobbeschreibung

Cencora, through Innomar Strategies, seeks a Manager, Quality Assurance (Consulting) to lead a Sr. QA Specialists team and support complex client quality deliverables in the Canadian market.

The role combines hands-on quality work with leadership, risk-based decisions, and proactive client engagement to ensure Health Canada compliance and robust GMP systems. You will mentor staff, manage audits, and drive continuous improvement across documentation, CAPAs, change controls, and training.