Pharmacovigilance Quality Assurance Manager

Offre d’emploi originale

The Pharmacovigilance Quality Assurance Manager leads the planning, conduct, and reporting of routine and non-routine GxP audits to ensure regulatory compliance. They also provide leadership during regulatory inspections, coach junior auditors, and manage cross-functional projects.

Détails du poste

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Toronto, Ontario, Canada Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for Pharmacovigilance Quality Assurance Manager. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States - Requisition Number: R-096642 Brazil - Requisition Number: R-097962 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Key responsibilities: Auditing Independently leads the planning, conduct, reporting of R&D Quality QA routine and non-routine audits/assessments/inspections of activities, data, internal facilities and processes in GxP/non-regulated to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope. Manages complex or business critical audits/issues in a supporting or leading role. Supports other auditors in planning, conduct and reporting of audits. Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities. Supports the CAPA process following the audit as needed. Encourages and supports others to properly manage and document the risk-based approach in the audit planning and conduct Inspection Support May participate in regulatory inspections in a leadership role (e.g. host, backroom lead) Training & Development Identifies training needs. Supports Development and provides training. Independently advises and coaches other auditors. Involved with the review and approval of curriculum as applicable Completes training requirements in a timely manner to ensure inspection readiness at all times. People Management Able to supervise junior auditors/contractors Deputizes for Team Lead, as required. Project Management Leads initiatives and actively participates in key projects across the organization or company. Interacts with key stakeholders and can influence and effectively drive projects to completion. Expertise Actively shares business area and regulatory knowledge/expertise. May act as a primary contact for internal and/or external stakeholders. Conducts Peer review of audit reports, as required. Independently provides consultation and advice to Business Partners on quality and compliance processes/procedures. Interprets and applies regulations/policies to unique and/or complex issues, when required. Qualifications Education: Minimum bachelor’s or equivalent University degree required; Focused degree in a life, natural, or computer science is preferred Experience and Skills: Required: A minimum of 6 years of relevant work experience in a GxP Regulated industry including 3 years in pharmacovigilance auditing Strong project management experience Strong verbal and written skills, including presentation skills. Strong teamwork and analytical skills Preferred: Experience in leading complex pharmacovigilance audit types e.g., system audits Other: Must be fluent in English. This position requires 25% domestic and international travel. #LI-Hybrid Required Skills: Preferred Skills: Business Alignment, Coaching, Collaboration, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility The anticipated base pay range for this position is : 112,150 CAD - 162,150 CAD Additional Description for Pay Transparency: - As applicable for the role - Under current guidelines, this position is eligible for a discretionary performance bonus. - The Company uses Artificial Intelligence in its assessment of applicants. - This job posting is for an existing position.

Ce que vous ferez

The Pharmacovigilance Quality Assurance Manager leads the planning, conduct, and reporting of routine and non-routine GxP audits to ensure regulatory compliance. They also provide leadership during regulatory inspections, coach junior auditors, and manage cross-functional projects.

Exigences

Candidates must possess a minimum of a bachelor's degree in a life, natural, or computer science and at least 6 years of experience in a GxP regulated industry. This includes a minimum of 3 years specifically in pharmacovigilance auditing.

Avantages

• Discretionary performance bonus

Compétences indiquées

• Continuous Improvement · Souhaitée
• Travail d’équipe · Souhaitée
• Assurance qualité · Souhaitée
• Analyse de données · Souhaitée
• Coaching · Souhaitée
• Gestion de projet · Souhaitée
• Stakeholder Management · Souhaitée

Autres compétences pertinentes

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Pharmacovigilance
• Quality Assurance
• Auditing
• GxP
• Project Management
• Risk-based approach
• Regulatory inspections
• Compliance management
• Coaching
• Stakeholder management
• Data analysis
• Technical credibility
• Standard operating procedures
• Quality management systems
• Continuous improvement
• Teamwork
• Compliance Management
• Influencing Skills
• Workplace Inclusivity
• Regulatory Environment
• People Management
• Planning
• Analytical Skills
• Quality Management Systems
• Peer Review
• Artificial Intelligence
• Audit Planning
• Auditor's Report
• ISO 9000 Series
• Good Manufacturing Practices
• Corrective And Preventive Action (CAPA)
• Decision Making
• Computer Science
• Continuous Improvement Process
• Due Diligence
• English Language
• Standard Operating Procedure
• Leadership
• Innovation
• Presentations
• Quality Management
• Safety Assurance
• Team Leadership
• Process Improvement
• Diagnostic Tools
• Business Alignment
• Quality Control

Domaines d’emploi

• Healthcare
• Management & Leadership
• Science & Research
• Consulting
• Pharmacovigilance Manager
• Quality Assurance Manager
• Management and Organization Analysts
• Quality Control Systems Managers
• Industrial Production Managers