MANAGER QA PROJECT AND REGULATORY SUPPORT

Janssen Cilag LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a Manager QA Project and Regulatory Support, to be located in Gurabo, PR.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease.
Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us.
We bring together the best minds and pursue the most promising science.
We are Janssen.
We collaborate with the world for the health of everyone in it.
Learn more at www.
anssen.
om and follow us @JanssenGlobal.
Janssen Cilag is part of the Janssen Pharmaceutical Companies.
Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity! As the Manager QA Project and Regulatory Support, you will be responsible to lead, manage and provide direction to the Quality Assurance activities related to process optimization, and validation in conformance with the current Good Manufacturing Practices, Janssen Supply Chain policies, standards, and internal procedures.
Reviews and approve regulatory submissions, support new market launches and provides input on sections/issues relevant to commercial operations.
Assures site compliance with regulations and expectations of those new markets.
Partners with the Compliance Team to perform mock pre-approval inspections at Gurabo or support external inspection activities.
Key Responsibilities.
The incumbent primary responsibility is to lead, direct and provide guidance on new market launches of products and technologies.
In addition, review and approve regulatory submissions and provides input on sections/issues relevant to commercial operations.
Responsible for quality assurance matters to the teams working in projects related to process optimization and validation in Gurabo.
Provides technical and quality assurance support in the resolution of quality/compliance related issues in projects.
Partners with the base business Quality Assurance groups to review and approve all documents that include but is not limited to change controls, protocols, reports, protocol discrepancies, non-conformances and technical documents that support projects and product divestment activities.
Partners with the Compliance Team to perform mock pre-approval inspections at Gurabo and provides support during FDA/International inspections.
Develop, supervise, coach and recognize personnel for optimal performance, as required.
Drives performance appraisal process and takes corrective and disciplinary actions as required by company policies and procedures.
Ensures that all Safety, GMP, Policies, Work Instructions and/or procedures are followed throughout the process.
Must be fully knowledgeable of Quality Risk Management concepts and should lead teams in the execution of Quality Risk Assessment exercises.
Qualifications Education.
A minimum of Bachelor's degree or equivalent degree is required.
Focus degree in Microbiology, Biology, Chemistry or related science are preferred.
Experience and Skills.
Required.
A minimum of 8-10 years of relevant work experience Experience in the Pharmaceutical manufacturing process environment.
Desirable experience in Parenterals.
Knowledgeable of US and International Regulatory Requirements.
Project Management Certification and Risk Management also desirable.
Knowledge in documents such as safety rules, Standard Operating Procedures, Work instructions, investigations, validation reports, and protocols.
Proficiency with Microsoft Office tools (Word, Excel, PowerPoint).
Must exercise judgment on the resolution of final release problems to meet company standards for quality, cost and critical success factors.
Preferred.
· Interpretation of industry guidelines and company policies to guide teams.
· Resolution of laboratory and manufacturing/packaging investigations.
· Critical review of content of documentation including regulatory submissions, works with team to decide on final content.
Provides Operations/QA perspective on many issues (e.
.
specs, Quality Agreements, validation parameters, etc.) and facilitates resolution of issues.
· Must exercise judgment on the resolution of production problems to meet company standards for quality, cost and critical success factors.
· This position requires availability for traveling, working irregular shifts, frequently requires working extended hours, and might be required to work on holidays and weekends.
Other.
The position requires employee to be fluent in Spanish and English and must have excellent ability to write in English and Spanish.
Ability to work first shift, including irregular (non-standard) shifts and weekends.
Frequently requires working extended hours and might be required to work on holidays.
Ability to travel domestically up to 10% of the time Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.