Pharmacovigilance Quality Assurance Manager

6010-Biosense Webster Inc. Legal Entity; São Paulo; Presencial; BRL 200 000 - 320 000; Tempo integral

Resumo da oferta

Johnson & Johnson is seeking an experienced Pharmacovigilance Quality Assurance Manager for São Paulo, Brazil. The role involves leading audits, ensuring regulatory compliance, and guiding QA processes across global sites.

You will coordinate risk-based audit planning, participate in inspections, and mentor junior auditors. The candidate should have at least 6 years in a GxP regulated setting, including 3 years in pharmacovigilance auditing, with strong project management and fluent English.

Qualificações

• Bachelor's degree or equivalent is required.
• Minimum 6 years of relevant work experience in a GxP regulated industry including 3 years in pharmacovigilance auditing.
• Fluent in English; strong communication and presentation skills.

Responsabilidades

• Audit planning, execution, reporting for R&D Quality QA routines and audits in GxP/non-regulated areas.
• Lead or support cross-functional, complex audits and inspections as applicable.
• Mentor junior auditors and support CAPA processes post-audit.
• Ensure adherence to SOPs, QA plans, and regulatory requirements.
• Travel up to 25% domestically and internationally as needed.

Conhecimentos

GxP Regulated

Pharmacovigilance auditing

Project management

Verbal & written skills

English fluency

Travel 25%

Formação académica

Bachelor's degree in life sciences or related

Descrição da oferta de emprego

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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

São Paulo, Brazil

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 Canada - Requisition Number: R-097969 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.
• 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

• 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

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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 https://www.jnj.com/.