Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Raritan, New Jersey, United States of America
Job Description:
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):
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
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
Project Management
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:
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:
Other:
#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 :
$102,000.00 - $177,100.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
