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.

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.

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.

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 meetings, 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.

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.

Preferred Skills

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

Benefits

• Employees and/or eligible dependents may be eligible to participate in the following Company-sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Employees are eligible for the following time off benefits:
  • 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

This position is located primarily in Malvern, PA, but may require up to 20% domestic travel to the Johnson & Johnson Innovative Medicine site in Spring House, PA.