Description
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:
QualityJob Sub Function:
Quality AssuranceJob Category:
ProfessionalAll Job Posting Locations:
São Paulo, BrazilJob 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
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