Quality Assurance QA Validation Associate Director
Quality Assurance QA Validation Associate Director
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1 Vacancy
Job Description
Position Overview
Summary:
Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking Quality Assurance (QA) Validation Associate Director to oversee the review and approval of commissioning qualification and validation protocols reports and discrepancies. This role will ensure compliance with FUJIFILM Diosynth Biotechnologies quality policies site SOPs and regulatory requirements while providing strategic leadership to the validation team.
Job Title: Quality Assurance (QA) Validation Associate Director
Reports to: Director Quality Assurance Compliance
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:
Leadership
- Develop implement and maintain QA oversight activities to meet all GMP guidance and direction to the validation team to ensure adherence to local and global quality standards regulatory requirements and partner commitments.
- Maintain an operational tier structure to ensure the site is continuously complying with standard operating procedures processes regulatory requirements and partner commitments.
- Identify and implement best practices to improve right first time (RFT) .
- Develop mentor motivate and lead direct reports to achieve individual and organizational objectives.
- Collaborate with cross functional teams and management to instill a Quality Culture by coaching personnel on GMP principles and their applications.
QA Validation and Compliance
- Review and approve master validation plans qualification/validation protocols summary reports and associated data to ensure regulatory and SOP compliance.
- Identify areas of risk and/or continuous improvement; escalate/communicate as appropriate.
- Oversee and approve validation deviations and discrepancies supporting investigations and corrective actions and participate in design reviews assess P&IDs and review engineering drawings for compliance.
- Collaborate with Validation Metrology Facilities and Engineering teams to ensure GMP protocols and requirements are met in a timely manner.
New Business Growth
- Lead the effort to support client due diligence quality audits and regulatory inspections to ensure compliance with industry and company standards.
- Perform other duties as assigned.
Required Skills & Abilities:
- Proven ability to motivate and lead teams instilling our Company philosophy culture and People Fundamentals.
- Experience in qualification/validation of process equipment clean utilities automation sterile filling aseptic processing HVAC systems and new GMP facility construction.
- Strong understanding of cGMP regulations for the production of drug biologics or vaccine products.
- Excellent written and verbal communication skills with strong organizational and analytical abilities
- Excellent organizational analytical data review and report writing skills.
- Ability to prioritize tasks multitask effectively and work independently with minimal supervision
- Develop staff to maximize contributions to the team and the company.
- Proficiency in Microsoft Excel Word and PowerPoint.
Qualifications:
- Bachelors degree with eight 8 years of relevant experience in a heavily regulated environment such as pharmaceutical biotechnology or supporting a CDMO environment; OR
- Associates degree with ten 10 years of relevant experience in a heavily regulated environment such as pharmaceutical biotechnology or supporting a CDMO environment.
- At least four 4 years of experience in a leadership or prior supervisory/managerial role.
- A minimum of five 5 years of experience working with biologics (vaccines gene therapy mAb etc. in a QA or QC role.
Preferred Qualifications:
- Degree in Biology Chemistry or Engineering.
- Single Use and Process Validation a plus.
- Previous leadership experience in Quality Control or Quality Assurance.
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.
- Potential for exposure to chemicals gases fumes odors dusts and other hazardous materials.
- 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.
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
