Senior Quality Manager

Janssen Biotech, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Manager! At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Redefining 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 and follow us @JanssenGlobal. The Senior Quality Manager role is accountable for leading a team of QA people leaders responsible for day-to-day oversight of the activities of the Quality Operations teams at GMP production facilities located at Malvern and Spring House, PA sites. Key Responsibilities: • Lead all aspects of several quality functions including investigations, corrective and preventative actions, product release, Shop Floor Oversight, Risk Management, and New Product Introduction and Technology Transfer • Set quality standards with respect to manufacturing and engineering systems and ensure compliance with those standards. • Primary person accountable for product release at both sites • Assures manufacturing and laboratories are inspection ready • Develops and cultivates an interpersonal culture that promotes behaviors that lead to outstanding business performance and interpersonal excellence. • Encourages and supports initiatives and programs that support improved quality and compliance. • Leads and guides staff and those involved in quality activities to achieve the best results. • Mentors and coaches staff, as well as develops and implements training programs, to ensure professional and personal development of quality personnel. • Connects professionally with other Janssen departments, as well as staff from other affiliates and Johnson & Johnson to fulfill their responsibilities. • Ensures all employees align with all applicable and governmental (HPRA, FDA, etc.) regulations, policies, and guidelines. Qualifications Education: • A minimum of a bachelor’s degree is required, preferably in a scientific or engineering field • Advanced degree in a scientific or engineering subject area preferred Experience and Skills: Required: • A minimum of eight (8) years of experience in a leadership position within the biological and/or pharmaceutical industry • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics, advanced therapies, or pharmaceuticals • Ability to apply GMP regulations and other FDA and international guidelines to the position • Demonstrated success in leading in a global organization • Gives operational direction to the QA teams in the execution of their duties. • Coordinates the work within quality to build a collaborative approach to goals and tasks. • Provides coaching, mentoring, and direction to Quality staff as appropriate. • Through personal expertise, leadership, and dedication, provides leadership to the site in the development of a culture of quality. Preferred: • A minimum of five (5) years supporting one or more functional area (e.g. R&D, Manufacturing, Engineering and/or Technical Services) • Proven strategic and business plan development Other: • May require up to 25% of domestic travel within Pennsylvania between Spring House and Malvern locations. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. 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.careers.jnj.com. Primary Location United States-Pennsylvania-Malvern-200 Great Valley Parkway Other Locations North America-United States-Pennsylvania-Spring House Organization Janssen Biotech, Inc. (6014) Job Function Quality Requisition ID 2206043982W