Sr Mgr Quality Assurance - QC Labs - 2406161396W

　　Description

　　Janssen Supply Group is recruiting for a Sr. Manager Quality Assurance, located in Malvern, PA!

　　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.janssen.com (file:///C:/Users/jamie yacco/AppData/Local/Microsoft/Windows/Temporary Internet Files/Content.Outlook/JHNHJA6O/www.janssen.com) and follow us @JanssenGlobal. Janssen Pharmaceuticals, LLC is part of the Janssen Pharmaceutical Companies.

　　In this position you will lead a team of associates responsible for handling all aspects of Quality Assurance oversight for GMP and R&D laboratories at the Malvern Campus, ensuring consistent delivery of pharmaceutical products that meet or exceed safety, regulatory compliance, and product performance standards.

　　Key Responsibilities:

　　Ensures compliance with global health authority regulations and Johnson and Johnson standards related to investigations, change control, and CAPA in a laboratory setting.

　　Resolves unplanned quality and compliance issues and drives continuous improvement to build an agile organization.

　　Leads approval of all required GMP documentation related to relevant R&D studies and laboratory operations.

　　Ensures all non-conformances are thoroughly investigated with root cause identified and appropriate CAPA’s implemented.

　　Supports continuous operational readiness for the QC laboratory during Project Phase, Scale up and routine Manufacturing operations.

　　Defines the strategy for implementation of phase appropriate GMPs for work performed in the relevant R&D laboratories.

　　Establishes effective partnerships with other individuals, departments, and cross- functional teams so that analytical services are well understood and coordinated.

　　Represents the Malvern Quality organization where appropriate in meetings and communications with regulatory authorities & industry meetings.

　　Qualifications

　　Education:

　　A minimum of a Bachelors Degree in engineering, science, or an equivalent technical field.

　　Advanced degree is preferred.

　　Experience and Skills:

　　Required:

　　A minimum of 8 years relevant experience within the pharmaceutical or biotech industry

　　Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production.

　　Proven ability to lead a team to successfully deliver complex projects.

　　Strong interpersonal and written/oral communication skills.

　　A focus on patients and customers at all times.

　　Preferred:

　　Experience working in a Quality Control lab is preferred

　　Experience with working in a global/matrix organization preferred

　　Other:

　　Up to 10% travel may be requiredJohnson & 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.careers.jnj.com .

　　Primary Location NA-US-Pennsylvania-Malvern

　　Organization JANSSEN SUPPLY GROUP, LLC (6046)

　　Travel Yes, 10 % of the Time

　　Job Function Quality Assurance

　　Req ID: 2406161396W