Quality Director

Quality Director

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.

We are currently seeking a Quality Director to join the Quality Team in Wilson, North Carolina.

While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both design & construction. For the project design phase, the role will require you to be present with our design teams in the Greater Philadelphia region. Once the design phase is completed, this role will support the construction and operational start-up of the site.

For this, you will be required to be on site in Wilson, NC. Based on your current location the hiring team will work with you to determine travel and relocation arrangements. In steady state, we expect travel to be less than 10%.

This Quality Director is responsible for leading and managing all Quality related programs and activities to support manufacturing operations. These functions and activities include Quality Control testing, Quality Assurance review and approval functions, Compliance activities, Product Release activities, etc. This role has the authority to make decisions in the following areas:

• Disposition of all incoming materials (incoming drug substance, excipients, components, packaging materials, etc.) and materials manufactured in the facilities at the site.
• Decisions with respect to Quality and Compliance.
• Reporting the Performance of the Quality System.

The initial 5 years of this role will predominantly focus on leading/directing all Quality aspects in completing the conceptual design, basis of design, detailed design, construction, commissioning/qualification, process validation, and regulatory submission/approval for this new U.S.

-based Biotherapeutic manufacturing facility.

Key Responsibilities:

• Provide overall Quality leadership and guidance to all site functional areas and management teams to ensure that business goals are achieved in compliance with all regulations and with a high level of quality meeting Johnson & Johnson's Quality Policy Standards.
• Develop and champion a Quality culture that promotes behaviors that lead to superior business performance and organizational excellence.
• Partner with peers in equivalent roles at other Innovative Medicine Supply Chain Sites to ensure harmonization and alignment with Innovative Medicine Supply Chain Quality Policies, Guidelines, Programs and Systems.
• Responsible for appropriately staffing and developing the Quality organization to meet business needs and succession plans. This includes mentoring and coaching staff as well as developing and implementing training programs, to ensure professional and personal development of department personnel.
• Ensures financial leadership by developing appropriate operating and capital expense budgets.

Qualifications:

• Requires a minimum of a bachelor's degree in science, Pharmaceutical Engineering, Engineering, Pharmacy, Biochemistry, Microbiology, Biology, Chemistry or Molecular Biology. Advanced degree in a scientific or engineering discipline is preferred.

Required Years of Related

Experience:

• 10-15 years' experience in a significant leadership position within the biological and/or pharmaceutical industry and 5 years' experience in a Quality leadership role required.
• Experience & Interaction with FDA/EMEA regulatory requirements applicable to biologics or pharmaceuticals.
• Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
• Proven success in managing within a global organization.
• Strong knowledge in regulatory compliance, Quality Systems, pharmaceutical industry, pharmaceutical methods and procedures and experience with regulatory inspections.
• Quality management skills: problem solving, statistical thinking, design of experiments, etc.
• Relationship skills: negotiation skills, presentation skills, able to read the corporate culture, listening skills, harvests people's energy, and manages diverse team members.
• Excellent interpersonal skills.
• Innovative, tenacious, and passionate about quality.
• Time management skills.
• Attention to detail without losing sight of the big picture.
• Keeps up to date with technical and managerial developments in the industry.
• Results and performance driven.
• Proven success as a People Leader.
• Adaptable and flexible.
• An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.
• Empowered professional who can make well motivated pragmatic decisions on his/her own.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate complex quality…