Johnson & Johnson Careers
Please enter a valid email.
Unfortunately, our network is not responding. Please try again later.
Your job alert was successfully created.
Senior Associate, Quality Systems
Requisition ID: 9466180419
Vogue International, a member of Johnson & Johnson's Family of Companies, is recruiting a Senior Associate, Quality Systems to be located in Clearwater, Florida.
Vogue International, a Johnson & Johnson Company, is an innovative consumer products business located in Clearwater, Florida, that distributes cutting-edge hair care products to large retail chains around the world. These brands represent an innovative hair care business which is new to our Consumer Family of Companies and focused on the marketing, development and distribution of salon-influenced and nature-inspired hair care and other personal care products. With several strong brands among its portfolio, including OGX® and MAUI MOISTURE® Proganix® and FX®, the Vogue business is the cornerstone of Johnson & Johnson Consumer’s hair care operations. Vogue International products are sold in the U.S. and in 38 countries.
The Senior Associate, Quality Systems is responsible for administration of the change control, internal audits, and quality records management processes while ensuring the Vogue portfolio of products conform to established standards, J&J Global and Regional policies and procedures, U.S. and Global Quality System Regulations (QSRs) including 21 CFR 210 & 211, 21 CFR 820 and 21 CFR Part 11 and current Good Manufacturing Practices.
In this role, you will also be responsible for Quality CAPA activities and assisting in continued Quality system development.
- Administration of the Change Control process ensuring the change request program meets the business needs, is in compliance with regulatory requirements, and meets J&J timeliness and compliance requirements.
- Trains new Vogue employees on the Change Control system and conducts refresher trainings as required.
- Tracks and reports metrics for Change Control for site reviews.
- Liaison between Quality and other Vogue functional areas for the completion and closure of CAPAs. Follow-up with applicable departments to ensure timely completion of CAPA activities.
- Develops, analyzes, and reports CAPA tracking/trending, CAPA effectiveness, and business performance metrics and reporting.
- Prepares and presents CAPA information for site reviews.
- Develops, improves, and implements CAPA programs/policies and procedures for Vogue. Ensures trending and reporting processes are integrated into procedures.
- Serve as SME for CAPA system maintenance and training.
- Creates the internal audit schedule.
- Identifies Lead Auditors and functions as a Lead Auditor when needed.
- Ensures internal audit observations are resolved and reported through management review and enterprise channels.
- Additional activities may include: site management review coordination, site inspection readiness and quality records management.
- A minimum of a Bachelor’s Degree is required. Advanced degree is preferred.
- A minimum 5 years of experience in the quality assurance and/or compliance is required.
- Experience in Quality Systems, Product Safety, Enterprise systems rollout, or Complaint vigilance/reporting is preferred.
- Detailed working knowledge of cGMP requirements and current FDA enforcement issues is required.
- Knowledge of Quality system regulations (ISO/GMP/BSI/FDA) is required
- Certification with one of the following: CQE, CRE and/or CQA is preferred.
- Strong organizational skills are required.
- This position may require up to 10% domestic and international travel as needed.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Vogue International LLC (6232)