Kelly Services Director of Quality, Radiopharmaceutical Industry in Somerset, New Jersey
Kelly Scientific Resources is currently seeking a Quality Director for one of our top clients in Somerset, NJ. This is a DIRECT HIRE POSITION!
The Director of Quality for Radiopharmaceutical Contract Manufacturing is committed to all aspects of Quality and Safety in the production of the Radiopharmaceutical products they manufacture. This is a new, high-profile role providing Quality leadership in a recently built, state of the art manufacturing facility in Somerset, New Jersey, manufacturing aseptically produced therapeutic and diagnostic radiopharmaceuticals. The successful candidate will play an active and integral part of the leadership team driving change through their direct reports as well as exerting influence at all levels of the organization.
Essential Duties and Responsibilities
Plan, direct, and control QA activities at the New Jersey site and throughout the network (where RCMO products are made).
Provide Quality Leadership to develop, maintain and continually improve the Quality Management System (QMS).
Ensure a culture of Quality is embedded throughout the operation.
Oversee all quality related activities of routine radiopharmaceutical manufacture.
Provide the QA input into technical transfer projects to ensure that internal and external requirements with regards to validation and cGMP manufacture will be met.
Provide QA activities at the New Jersey facility such as:
Associated Subcontractor activities and facilities
Maintain and enhance the QMS to ensure compliance with the spirit and letter of the relevant cGMP guidelines.
Foster an environment of continuous improvement and ensure a culture of compliance is maintained across the sites, including contributing to the development of policy and standards within the QA organization.
Provide QA expertise, especially in aseptic manufacturing and sterility assurance.
Liaise with the FDA with regards to site licenses and GXP activities including, product license submissions and product quality and distribution-related issues as necessary.
Serve as the face of Quality in Radiopharmaceutical Contract Manufacturing Division to all potential and current customers.
Host regulatory and customer audits and formally respond to any observations.
Work with customers in the transfer of new products into the network, ensuring qualification, validation and cGMP requirements and documentation are complied with.
Lead and manage the QA group through recruitment, development, appraisal, and motivation and by example.
Enable staff to fulfil their potential and maximize their contribution to the company.
Set, agree, monitor, and improve on key performance indicators to improve productivity, safety, and quality, and to provide management with a “virtual view” of the health of the QMS.
To be accountable for revenue and capital budgets, monitor performance and take appropriate action to ensure spend is proportional and consistent with the objectives of the unit.
Lead and or participate in major projects representing QA.
Ensure that operational staff are appropriately educated and trained for their roles.
Ensure that the QA team (VP and other Directors) provide appropriate cGMP training to operational staff.
Work with the QA team (VP and other Directors) to create and execute on training for all RCMO products in the network.
Work with the QA team (VP and other Directors) to deploy and maintain a risk-based vendor management process to assess new and existing suppliers.
Ensure data integrity is maintained for all systems and operations.
Devise a rolling internal QA schedule for execution by the QA specialists.
Review and approval of all Quality critical documentation for change management using “Risk-Based” methodology to ensure Quality is not compromised.
Ensure that CAPA’s and unexpected deviations are appropriately raised, investigated, and formally documented using appropriate Root Cause Analysis tools. Agree remedial actions and time frames whilst ensuring risks associated with the change are formally evaluated.
Bachelor’s degree (B.S.) in an appropriate scientific subject e.g. Chemistry, Microbiology, etc.
Direct experience in the manufacture of sterile pharmaceutical manufacturing (e.g. Senior QA role within a major pharmaceutical project).
6+ years supervisory or management experience in a relevant field in the pharmaceutical industry.
Expertise on 21 CFR 212 and 211 required, with extensive experience of other global regulatory authorities preferred.
This includes up-to-date knowledge of pharmaceutical legislation and best practice to ensure continued compliance with cGMP.
Excellent communication skills and an ability to lead change through others both direct reports and others.
Ability to deal with multiple demands and prioritize under pressure required.
Proactivity in identifying cost effective and compliant opportunities for simplification required.
Aseptic working within barrier technology required.
Computer literacy, e.g. Microsoft office, LIMS, HPLC software, SharePoint, required.
Travel: up to 25% domestically or internationally.
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm