Janssen Biotech, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Assurance Lead! This position can be located in Malvern or Spring House, PA!

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

In this role, you will be leading a team of Quality Assurance specialists responsible for the quality oversight of supply chain operations supporting production of commercial and clinical drug substance in the biotherapeutics product portfolio. You will act as a liaison with other internal quality organizations to standardize policies, practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns.

• Provide leadership and guidance to the Quality Assurance team responsible for product release, approval of manufacturing-related documentation and standard operating procedures, quality risk management, and quality oversight of nonconformance investigations and CAPA plans, change controls, new product introduction and technology transfer activities.
• Collaborate with business partners and provide meaningful guidance to help facilitate resolution of issues across organizational boundaries.
• Maintain a high caliber team through performance management, succession planning, talent management, recruiting, staffing, and making hiring decisions, and training and development processes. Train, develop, coach and mentor employees.
• Create and maintain an environment that serves as a learning atmosphere and fosters diversity, equity, and inclusion
• Cascade and translate strategic and tactical plans to foster your team's understanding of their contribution to achieving higher level goals including business unit and company business objectives.
• Lead the execution of the business plan by providing input on the site goals and objectives, prioritizing projects, and coordinating resource allocation to meet base business needs and support site and business initiatives related to quality and compliance.
• Contribute to establishing and monitoring quality metrics that serve as a key method of communication while establishing and maintaining a climate of open communication, engagement and ownership.
• Ensure that cycle times are met within quality functional areas. Collaborate with your team to address delays or issues and identify and implement efficiencies to reduce E2E cycle times.
• Lead inspection readiness activities and internal and external audits.
• Provide leadership and insight as on global project teams.
• Other duties may be assigned as necessary.

• At least 6 years of experience in a regulated manufacturing environment is required, preferably in biotechnology or pharmaceutical industry.
• Advanced knowledge of cGMP regulations and FDA/EU guidance related to biologics or advanced therapies is required.
• Demonstrated experience directly supervising employees is required.
• Ability to quickly process complex information and often make critical decisions with limited information is preferred.
• Ability to prioritize daily business needs while being flexible and adaptable to frequently shifting priorities is preferred.
• Ability to be organized and capable of working in a team environment with a positive demeanor is required.
• A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills are required.
• This position is located primarily in Malvern, PA, but will require up to 20% domestic travel to the Janssen site in Spring House, PA.