Johnson & Johnson Careers
Senior R&D Quality & Compliance Specialist M/F
Requisition ID: 1805704470W
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Johnson & Johnson has an open culture with strong principles that have been incorporated in our company credo. This is an opportunity for you to become part of our talented team delivering to stretch targets in a dynamic business environment. We are on a journey to implement state of the art technology which comes with many opportunities to further develop your skill set.
For our Consumer business, we are recruiting on a permanent contract a Senior Specialist, R&D Quality & Compliance to be based in Val-de-Reuil, France.
POSITION SUMMARY :
The Senior Specialist R&D Quality & Compliance (R&D Q&C) is responsible for the administration of integrated and comprehensive quality systems and controls that are appropriate, effective, efficient and continuously improving in order to ensure that R&D functions are operating in full compliance with sound scientific practice, Current Good Manufacturing Practices (CGMP) and within Johnson & Johnson policies and Standard Operating Procedures.
The Senior Specialist is responsible for quality review/approval of NPD/SMP project related documentation including but not limited to protocols, process/analytical reports, method validation reports, test methods, specifications, deviations/investigations and APR review.
The Specialist will also be responsible for general compliance support such as review and approval of standard operating procedures, batch records, packaging dossiers, Certificates of Analysis and release of study materials related to the projects.
Function as an advisor providing guidance on applicable Regulations (ISO, FDA, ICH, EU, and others) pertaining to business partners.
70% of time :
- Participate on R&D project teams as the Quality representative. The Specialist will work with these groups relative to compliance of development processes and deliverables with regulatory and company requirements, GMP issues, project plans, due dates, and problem identification and resolution along with ensuring documentation compliance to release R&D studies.
- Provide Quality guidance on GMP regulatory requirements including training of R&D personnel.
- Provide GMP documentation review and approval of batch records (Manufacturing, Packaging, and Labeling) and related documents, including Lab, Pilot, and Trial scale batches. Responsible for the quality inspection of supplies for R&D studies.
- Participates in the development and implementation of GMP and/or quality processes and procedures in R&D and in particular for Pomezia R&D.
- Implementation and follow-up of actions to improve the quality and the conformity of the operations of the site with the good practices in force and the requirements of the group. Identification and proposal of continuous improvement initiatives on the quality system and/or practices of the site. Participation in the development and application of GMP and quality and compliance processes and procedures on the site.
- Training process owner for R&D EMEA non-OTC
- Participate in the development and implementation of GMP and Quality & Compliance processes and procedures. Participate in inspection readiness activities.
Internal: Will interact and collaborate with J&J Consumer Q&C functions within and across the region.
Will interact and collaborate with J&J Consumer R&D Product Development, Technology & Deployment (Analytical/Micro, Pilot Plant, Tech Transfer, SMP, & Labeling), Marketing, & Engineering Departments.
External: May liaise with Contract Facilities to ensure compliance with J&J standards and regulatory requirements, including developing and implementing Quality Agreements, reviewing documentation to ensure compliance, and generate metrics around key quality performance indicators.
KNOWLEDGE SKILL AND ABILITY REQUIREMENTS :Background :
- Minimum of BS Degree in Chemistry, Biology, Pharmacy, Engineering or other scientific related subjects.
- 5-10 years of experience with minimum of 2 years experience in Quality Assurance in pharmaceutical, consumer products or any other Regulated environment.
- Experience of the overall product development process.
- Expert knowledge of applicable regulatory requirements (cGMPs) governing various product classification types (cosmetic, OTC/OTC Monograph and Medical Devices).
- Ability to work and make decisions independently and on multiple projects
- Ability to engage and align with other diverse and dispersed organizations and functions.
- Excellent knowledge of English is required and proficiencies in Microsoft Office applications.
- Problem solver
- Proactive strategic thinker
- Highly committed to quality
- Flexible and persistent
- Good conflict handling/negotiation skills
- Ability to independently plan, organize, co-ordinate, manage and execute assigned tasks
- Excellent communicator, interpersonal skills and diplomacy
- Excellent knowledge of procedures governing R&D GMP and Analytical/Micro activities
- Good knowledge of procedures governing computer system validation, digital application development.
Johnson & Johnson Santé Beauté France SAS (7101)