Associate Director QC Compliance
Associate Director QC Compliance
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Position Overview
The Associate Director of Quality Control Compliance is a pivotal role within the Quality Control department responsible for ensuring adherence to quality systems and regulatory standards. This position is dedicated to overseeing key QC processes including the lifecycle management of QC SOPs training curricula change control deviation management and data integrity. This leader will drive compliance within the Quality Control function.
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
Reports to Head of Quality Control
Work Location College Station TX
Primary Responsibilities:
Compliance with Quality Systems:
- Lead efforts to ensure that Quality Control processes are in full compliance with established quality systems and GMP regulations.
- Collaborate with the Quality Assurance team to align QC practices with overarching quality standards without duplicating roles in QA.
Quality Standards and Process Management:
- Oversee the lifecycle management of Quality Control Standard Operating Procedures (SOPs) ensuring they meet quality requirements and are consistently followed.
- Develop and maintain effective training programs to enhance QC staff competence in compliance with quality systems.
Training Coordination and Effectiveness:
- Organize and oversee training activities ensuring all QC personnel are knowledgeable and proficient in QC procedures and regulations.
- Evaluate the effectiveness of training programs making adjustments to optimize learning outcomes and compliance adherence.
Change Control Management:
- Manage change control activities related to QC methods equipment and processes to maintain continuous compliance.
- Ensure thorough documentation and implementation of changes to uphold product quality and regulatory standards.
Leadership:
- Manage and mentor a team of QC Compliance professionals fostering a positive and collaborative work environment.
Deviation Management and Trending:
- Lead deviation investigations within QC ensuring robust root cause analysis (RCA) and application of corrective and preventive actions (CAPA).
- Conduct trend analysis on deviations to identify areas for process improvement and enhance compliance.
GMP Documentation and Data Integrity:
- Ensure meticulous compliance with Good Documentation Practices (GDP) and data integrity throughout QC operations.
- Conduct holistic reviews of testing batch records and stability studies to identify trends and rectify discrepancies.
Data Trending and Analysis:
- Direct data trending and analysis efforts to provide valuable insights into QC performance helping drive improvements in quality and stability.
- Collaborate with QC teams to implement databacked improvements that support compliance and quality enhancement.
- All other duties as assigned.
Qualifications:
- Bachelors degree in Chemistry Biology or other scientific discipline and 8 years of experience in Quality Control/Quality Assurance within the pharmaceutical/biopharmaceutical industry focused on compliance and quality systems.
- 5 years of leadership experience required.
- Experience with data integrity and compliance as related to quality control labs preferred.
- Advanced degree preferred.
- Strong understanding of GMP regulations and QC process management.
- Demonstrated leadership abilities.
- Demonstrated expertise in deviation management RCA CAPA change control and data integrity.
- Strong leadership skills with excellent project management capabilities.
- Highly analytical with strong problemsolving skills and a focus on compliance.
- Excellent communication and interpersonal skills to work effectively across departments.
- Role model for company core values of trust delighting our customers Gemba and Genki.
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 as needed.
- Onsite attendance is required.
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.
*LIOnsite
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
