Associate Manager, QA Operations

Position Overview

The QA Associate Manager (Operations DSM Upstream) leads and supervises a team of QA professionals responsible for providing day-to-day risk-based QA support of Drug Substance Manufacturing areas and processes in a fast-paced, dynamic startup environment. This role is the primary point of contact for their team and the first-line escalation point in areas of their responsibility. This role requires collaboration with leadership, site-based customers, and global colleagues.

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies 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.

 

Join us

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.

 

Job Description

What You'll Do

 

• Provides supervision of the QA Operations DSM Upstream team. Ensures allocation of adequate resources for shop floor QA activities (e.g., BPR review, event triage), QA support activities (e.g., DR/CAPA review and approval, changeover and area release), and technical QA activities (e.g., CC review and approval, WO oversight).• Leads cross-functional teams to achieve operational readiness objectives and new product introduction goals using a risk-based, right-size approach.• Collaborates with Responsible Person(s) to facilitate timely disposition of DS material.• Serves as Subject Matter Expert in audits and inspections for their area of responsibility.• Establishes and maintains internal and external training goals for self and team to ensure compliance with cGMPs and regulatory requirements.• Provides training, coaching, and mentorship to their team and peers as applicable. Works with their team to identify areas for improvement, reduce blind spots, and give opportunities for increasing responsibility as appropriate for each individual's career objectives.• Identifies and leads process optimization initiatives and continuous improvement tasks in their area of responsibility.• Applies expertise in manufacturing QA concepts and business knowledge to act as the primary point of contact for their team and the first-line escalation point in areas of their responsibility.• Gathers recommendations for enhancements and gaps related to their areas of responsibility and, in collaboration with leadership, prioritizes and implements solutions accordingly.• Establishes a QC Sample Control laboratory including, but not limited to: SOP creation, training plan for team, inventory management, delivery of operational and inspection readiness goals, leading in both a project and routine operations environment.• Maintains relationships with site-based customers and global colleagues and provides updates to leadership as requested.• Performs other tasks as assigned.

 

Minimum Requirements

 

• Bachelor’s degree in Life Sciences or Engineering and 8+ years of experience in GMP quality assurance and/or similar role OR• Master’s degree in Life Sciences or Engineering and 6+ years of experience in GMP quality assurance and/or similar role.• 2+ years of direct supervisory experience• Excellent oral and written communication skills

 

Preferred Requirements 

 

• Working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software is a plus• Understanding of the following processes preferred such as cell culture or fermentation.• Experience with complex projects and the ability to keep work pace and meet deadlines with good organization and planning skills.• High level of familiarity/understanding of production equipment, hyg