Senior Quality Lead

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America

Job Description:

Johnson and Johnson Innovative Medicine, is recruiting for a Senior Quality Lead! This position will be located in Malvern, PA, with considerations given to Spring House, PA.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

On this team, we provide end to end quality oversight of GMP manufacturing areas including large molecule drug substances and cell banking operations. 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.

Main responsibilities will include, but are not limited to:

• Partner with Research & Development and Supply Chain teams to support GMP manufacture of cell banks, clinical products, medias, and buffers.
• Collaborate with business partners to support new product introductions and manage team to ensure timelines are met for all Quality deliverables.
• Represent the lead Quality Operations role at daily huddles, triages, tier meeting, and meetings with business partners.
• Maintain GMP environments in inspection ready state by participating and managing scheduled oversight of manufacturing areas.
• Review and approve controlled documents including standard operating procedures, work instructions, and risk assessments. Serve as lead for risk assessments and escalate risks as required.
• Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.
• Support change management processes including formal change controls by evaluating the proposed changes, assessing impact, providing quality input on implementation plans, and approving changes.
• Manage team to provide on time batch record review
• Support team with critical alarm review and unexpected event management.
• Support in process improvement activities including assessing current processes, providing improvement input and working with partners to implement changes. Support staff with continuous improvement projects.
• Support site inspections and inspection readiness activities.
• Train, Develop, Coach, and Mentor employees.
• Other duties may be assigned as necessary.

Qualifications

Education:

A minimum of a Bachelor’s Degree is required with a focus in Engineering, Biology, Biochemistry, Microbiology, Chemistry, or relevant scientific field/equivalent technical field preferred.

Required:

• At least 6 years of experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry.
• Ability to maintain written records of work performed in paper-based and computerized quality systems.
• Ability to quickly process complex information and often make critical decisions with limited information.
• Ability to work independently on routine tasks and require some supervision on complex issues.
• Ability to be organized and capable of wor