Senior Quality Lead

Johnson & Johnson Innovative Medicine • Malvern, PA

2d • Hybrid

About The Position

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. 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. 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.

Requirements

• 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.
• 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 working in a team environment with a positive demeanor.
• Manage multiple priorities daily while being flexible and responsive to frequently shifting priorities.
• A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills.
• Working knowledge of cGMP regulations and FDA/EU guidance related to biologics and cell banking

Nice To Haves

• Experience in Quality or Manufacturing for Large Molecule Manufacturing
• Working knowledge of Phase Appropriate GMP practices.
• Experience with document reviews and regulatory inspection processes is preferred.
• Demonstrate influencing skills, partnering and collaboration skills, analytical skills, and good oral and written presentation skills.

Responsibilities

• 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.

Benefits

• medical
• dental
• vision
• life insurance
• short- and long-term disability
• business accident insurance
• group legal insurance
• consolidated retirement plan (pension)
• savings plan (401(k))
• long-term incentive program
• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior