Associate Manager QA Operations

The QA Associate Manager (Operations DSM Upstream) leads and supervises a team of QA professionals responsible for providing daytoday riskbased QA support of Drug Substance Manufacturing areas and processes in a fastpaced dynamic startup environment. This role is the primary point of contact
for their team and the firstline escalation point in areas of their responsibility. This role requires collaboration with leadership sitebased customers and
global colleagues.

Follow Your Genki to North Americas largest stateoftheart Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples 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 newlargescale 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 endtoend cell culture CDMO provider in North America.

The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.

What Youll 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 crossfunctional teams to achieve operational readiness objectives and new product introduction goals using a riskbased rightsize 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 individuals 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 firstline 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 sitebased customers and global colleagues and provides updates to leadership as requested.
Performs other tasks as assigned.

Minimum Requirements

Bachelors degree in Life Sciences or Engineering and 8 years of
experience in GMP quality assurance and/or similar role OR
Masters 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 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

Training and/or familiarity with Quality Risk Management principles preferred

Working & Physical Conditions

May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.

Ability to ascend or descend ladders scaffolding ramps etc.

Ability to stand for prolonged periods of time up to 60 minutes.

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

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

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 viaemail 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.

Fujifilm is committedto 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.

If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .