QC Lab Services Manager

Johnson & Johnson Innovative Medicine•Wilson, NC

11d

About The Position

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 We are currently seeking a Quality Control Lab Services Manager, to join the Quality Team for the new Johnson & Johnson Large Molecule Drug Substance Manufacturing facility 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%. J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J’s significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations. The QC Lab Services Manager is responsible for leading the Quality Control laboratory services support including Lab documentation management, material/supplies purchase, eLims support, laboratory equipment lifecycle management and CSV support coordination, among others.

Requirements

Bachelor's degree in a scientific or engineering discipline.
Minimum of 6 years of experience working within the biological and/or pharmaceutical industry.
Experience in a Quality leadership role.
Analytical equipment qualification experience.
Experience working with Quality Control laboratory services support including Lab documentation management, material/supplies purchase, eLims support, laboratory equipment lifecycle management, systems and/or CSV support coordination.
Deep understanding and experience in application of global regulatory (FDA, EMA, ICH, etc.) guidelines in a biological or pharmaceutical manufacturing environment.
Experience interacting with health authorities and taking a leading role in regulatory inspections and audits.
An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.
Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate complex quality concepts to stakeholders at all levels.
Strong analytical and problem-solving skills, with a track record in leading investigations and implementing effective CAPAs.
Proven ability to manage multiple priorities and work independently with minimal supervision.
Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements.
Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment.
Ability to build and nurture strong and positive relationships.
The ability to work in a team environment and interact with all levels of the organization.
Results-driven leader who commits to stretch goals and delivers results.

Nice To Haves

Experience in supporting functional area (e.g., Manufacturing, Technical Operations, Engineering & Maintenance, R&D, etc.).
Certification in quality management systems (e.g., Certified Quality Manager, Certified Quality Auditor).

Responsibilities

Responsible for the Quality Control laboratory services support including Lab documentation management, material/supplies purchase, eLims support, laboratory equipment lifecycle management and CSV support coordination, among others.
Perform budget support as the point of contact for activities related to CAPEX, CIP tracking /reporting and spend tracking and reporting.
Support and facilitate the performance management and laboratory planning processes through the laboratory scheduling/planning tools, reporting scorecard metrics and monitoring laboratory indicators.
Lead QC project activities to introduce new products, technologies and computer base applications to improve laboratory efficiency and promote culture of Innovation.
Connect with the QC Global organization being the point of contact for the different center of excellence for equipment and information technologies.
Manage the development of a long-term vision and strategy for these quality systems in close cooperation with the site leadership and translating these strategies into compliant programs and processes in line with regulations and business expectations.
Responsible for the site’s Management Review program including the Quality metrics program, to ensure and proactively enhance compliance and business performance of the site.
Responsible for hiring, managing, leading, and motivating the Quality Systems team; inclusive of mentoring, training, and development of department employees.
Manage the resolution of unexpected complex compliance or quality system issues as they arise
Keep abreast of regulatory changes and industry best practices related to laboratory services and ensure timely implementation of necessary updates.
Manage relationships with external regulatory agencies and auditors, supporting inspections and audits, as required.
Drive a culture of quality throughout the organization, promoting a proactive approach to quality management and fostering a continuous improvement mindset.
Support the development of the Quality department budget in line with routine business planning cycles.