QA Associate Director Quality Operations
QA Associate Director Quality Operations
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1 Vacancy
Job Description
Position Overview
Summary: The Associate Director (AD) Quality Operations is responsible for QA oversight of cGMP operations and areas at one of the manufacturing facilities or the Quality Control unit at FDBT. This role is expected to lead a value stream such as TBF FBF NCTM or Analytical Development under the guidance of the Sr Director Quality Operations lead the Quality Operations organization to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external stakeholders. Direct all QA onthefloor batch record or QC data review and product disposition activities including QA review and approval of any associated deviations CAPAs and change controls to meet established targets for right firsttime and ontime delivery. Ensure products are manufactured to meet all cGMP regulatory requirements for phaseappropriate clinical and commercial bulk drug substance and drug product manufacture.
Company Overview
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 FDB and help create 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 FUJIFILM Diosynth Biotechnologies call Genki.
College Station Texas may be a small university town but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of smalltown life and the convenience of living close to the vibrant pulse of big cities. Eightyseven percent of Texas population lives within a 180mile radius so we are in the center of it all in Texas. And our site is nestled in the hub of innovation representing a source of pride for the area.
Job Description
Essential Functions:
- Develop implement and maintain QA oversight activities to meet all cGMP regulatory requirements for phaseappropriate clinical and commercial bulk drug substance and drug product manufacture.
- Maintain an operational tier structure to ensure the site is continuously complying with standard operating procedures processes regulatory requirements and partner commitments.
- Lead the Quality Operations team to deliver exceptional performance of each assigned area.
- Readiness activities before manufacture.
- Oversight activities during manufacture.
- Review activities after manufacture.
- Perform QA review and approval of deviations CAPAs and change controls.
- Identify and implement best practices to improve right first time (RFT) .
- Disposition products that meet all requirements on time based on established commitments.
- Liaise with internal and external stakeholders to achieve expected business outcomes.
- Partner with Quality Compliance to ensure the site is always inspection ready.
- Identify areas of risk and/or continuous improvement; escalate/communicate as appropriate.
- Provide expert guidance and interpretation on procedural requirements.
- Recruit hire and manage the team in line with FDBT policies and practices.
- Ability to serve as deputy for Sr Director Quality Operations.
- Any other duties as assigned.
Required Skills & Abilities:
- Strong understanding of Quality Systems.
- Excellent written and oral communication skills.
- Excellent organizational analytical data review and report writing skills.
- Ability to set personal performance goals and provide input to departmental objectives.
- Develop staff to maximize contributions to the team and the company.
- Ability to multitask and easily prioritize work.
- Ability to work independently with little supervision.
- Proficient in Microsoft Excel Word and PowerPoint.
- All candidates must have a working knowledge of cGMP regulations for the production of drug substance drug product biologics vaccine and/or advanced therapy products.
- The individual must possess a strong EHS and Quality compliance ethics and be able to lead by example.
- Experience of working with and influencing senior managers and customers.
- The individual must have excellent interpersonal skills which will enable them to communicate effectively.
- The individual must be able to work flexibly in high pressure environments and be able to make appropriate decisions quickly if required to do so.
- Able to build and maintain effective and credible relationships with key stakeholders and across all areas of the business.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the employee is regularly required to:
- Experience prolonged standing some bending stooping and stretching.
- Ability to sit for long periods to work on a computer.
- Ability to wear personal protective equipment including but not limited to safety glasses lab coat gloves specialized clothing including laboratory scrubs (pants and shirt) cleanroom (ISO 8 to ISO 5 gowning material and appropriate shoes required in most areas associated with this position.
- Lifting up to 25 pounds on occasion.
- Use handeye coordination and manual dexterity sufficient to operate a keyboard photocopier telephone calculator and other office equipment is required.
- Must be willing to work flexible hours.
- Ability to work weekends and offshift hours as needed to support manufacturing activities.
- Must be willing to travel occasionally as needed.
- Attendance is mandatory.
Qualifications:
- Bachelors degree with 8 years of relevant experience in a regulated pharmaceutical biotechnology or supporting a CDMO environment; OR
- Associates degree with 10 years of relevant experience in a regulated pharmaceutical biotechnology or supporting a CDMO environment.
- At least 4 years of experience in a supervisory or managerial role.
- A minimum of 5 years of experience working with biologics (vaccines gene therapy mAb etc. in a QA or QC role.
Preferred Qualifications:
- Experience within CDMO
- Advanced Degree
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.
EEO Information
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.
ADA Information
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 or.
Required Experience:
Director
Employment Type
Unclear
