Supervisor, QA Operations - Nights

Position Overview

The Supervisor, Quality Assurance Operations is responsible for providing supervision and risk-based QA support for the Drug Substance Manufacturing areas and processes.

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

• Oversees Quality Assurance (QA) Operations Drug Substance Manufacturing (DSM) team on night shift (1800-0600 in a 2-2-3 cadence)• Applies expertise in manufacturing QA concepts and business knowledge to act as primary point of contact for their team and 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 prioritize and implement solutions accordingly• Maintains relationships with site-based customers and global colleagues and provide updates to leadership as requested• 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)• Collaborates with Responsible Person(s) to facilitate timely disposition of DS material• Serves as Subject Matter Expert (SME) in audit and inspections for DSM area.• 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 of their team and peers as applicable. Work with their team to identify areas of improvement, reduce blind spots and give opportunities for increasing responsibility as appropriate for each individual’s career objectives. • Administers company policies such as time off, shift work, and inclement weather that directly impact employees• Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)• Coaches and guides direct reports to foster professional development• Participates in the recruitment process and retention strategies to attract and retain talent, as needed• Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution• Performs other duties, as assigned

Minimum Requirements:

• HS diploma or GED with 8+ years’ experience from similar role in large pharma/biotech operations or projects OR• Associate degree in Life-Sciences and 6+ years’ experience from similar role in large pharma/biotech operations or projects OR• BA/BS Life Sciences Degree with 4+ years’ experience from similar role in large pharma/biotech operations or projects OR• 2-3 years of people management experience• Experience working in a GMP environment

Preferred Requirements:

• MS in Life Sciences or Engineering• Working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software• Understanding of large-scale drug substance manufacturing processes• Familiar with Technology Transfer and/or Product Commercialization processes• High level of familiarity/understanding of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and/or validation methodologies• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11• Occasional opportunity International and/or Domestic travel may be available

• Training and/or familiarity with Quality Risk Management principles preferred

Physical and Work Environment Requirements:

Ability to discern audible cues.

Ability to ascend or descend ladders, scaffolding, ramps, etc.

Ability to stand for prolonged periods of time up to 30 minutes

Ability to sit for prolonged periods of time up to 30 minutes

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).