The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
Supplier quality management begins early in the product design and supplier selection process. It continues through the entire life cycle of a product or service and for the duration of the relationship with that particular supplier.
This position provides supplier oversight to ensure that suppliers of services or materials to FDB are of the highest quality while conforming to pre-established requirements including cGMP's.
The primary responsibilities will focus on supplier quality, working with suppliers to maintain supplier approvals. Initially, this position will be key to the establishment of the Supplier Quality System including but not limited to SOP and Specification development, Quality Agreements, Risk Assessments, Supplier Auditing and Supplier Change Notifications. The ability to effectively collaborate, influence, and coordinate amongst suppliers and team members within Supply Chain, Quality Control and Quality Management is critical to this role.
- Independently prepares, conducts, and reports results of audits of GMP service providers and suppliers of various GMP materials, and internal processes to meet quality compliance requirements.
- Creates and maintains a list of approved suppliers/service providers.
- Establishes and maintain policies, procedures, checklists, self-assessment surveys, and additional forms for the internal and supplier audit programs.
- Monitors raw material supplier quality and works directly with Supply Chain, QA, and suppliers to improve performance.
- Oversee and report on the progress of audit corrective and preventative actions and audit findings for both the internal and supplier audit programs during Quality Management Meetings.
- Supports Quality management contact with the FDA, EMA and other regulatory authorities worldwide as well as partners regarding quality issues including field alerts, recalls or regulatory actions.
- Supports GMP inspections and audits from both regulatory authorities and partners and supports drafting of follow-up responses for all aspects of the business.
- Supports other GXP functions as required.
- Supports and participates in the supplier change notification process.
- Bring contagious positive enthusiasm and an agile proactive mindset to quality and cGMP compliance.
- 3-5 years of experience in Supplier Quality for pharmaceutical or biotechnology manufacturing
- Capable of partnering to assure suitability and/or cGMP compliance of the Supplier Quality program.
- Have excellent communication and presentation skills and be able to articulate complex information to stakeholders and partners that utilize the Supplier Quality systems including regulators and customers.
- Experience with complex projects and the ability to keep work pace and meet deadlines with good organization and planning skills.
- Solid understanding of supplier quality systems and continuous process improvement principles including global cGMP requirements, and other relevant regulations and guidance to assure quality products.
- Demonstrated ability to work in a multi-disciplinary setting, acting as a facilitator to drive fulfillment of strategic goals.
- Background in continuous improvement and implementation of quality metrics.
- Ability to anticipate and resolve problems effectively.
- Strong verbal communication and technical writing skills.
- Ability to present clearly using scientific and clinical terminology.
- Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings.
- Sound organizational skills.
- Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.
- Project management skills and focus on delivery of results.
- Role model for company core values of trust, delighting our customers, Gemba, and Genki.