What are the responsibilities and job description for the Director, Quality Control - Raw Materials position at Forge Biologics?
Job Description
Job Description
About the role :
We are currently seeking a Director, Quality Control to join the Forge Biologics team. The Director of Quality Control (QC) will actively contribute to the strategic, operational, and laboratory activities required to support the development and management of the raw material testing program. The Director manages the personnel in the QC Raw Material department and will collaborate with internal Manufacturing, Supply Chain, Facilities, and Quality Senior Management, as well as external suppliers, to address quality-related issues.
What you'll do :
- Provides strategic and operational leadership to a Quality Control department responsible for raw material sample receipt, incoming inspection and testing, and release of all starting materials (raw materials, consumables, etc.).
- Provides strategic leadership and guidance to the organization to develop and implement a material qualification program in a phase-appropriate fashion, to support pre-clinical, clinical, and commercial activities.
- Remains current on new technologies, and regulatory requirements that may have an impact on the company's development, while ensuring adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
- Accountable for ensuring adherence to strict regulatory requirements to ensure product quality.
- Contributes to authoring and / or reviewing QC reports, SOPs, QC protocols, comparability protocols and reports, and justification of specifications.
- Works directly with Leadership and Senior Management to assure process communications are occurring in a timely manner, and budget and timelines are being adhered to.
- Serve as a Subject matter expert (SME) for raw materials issues, providing technical expertise aligned with current GMPs and current industry best practices.
- Participates in the Engineering effort (i.e., CAPEX) to assure analytical equipment and supporting materials are in place and meet GMP requirements from design through procurement, installation and operational readiness, and associated required documentation.
- Create, review, and approve out-of-specification (OOS) and out-of-trend (OOT) investigations, deviations, CAPAs, and Change Controls.
What you'll bring :
Life at Forge :
We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge's core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.
HARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.
OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.
PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.
ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge's vision, mission and goals.
We've Got You Covered :
We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable.
