What Youll Do
- Develops strategic plans for QA team operations sets measurable goals and oversees the supervision development and performance of personnel to foster a high-performing team environment
- Leads and manages the QA DSM Operations teams including the Batch Review and Release teams and the Quality Engineering/Validation team ensuring alignment with organizational goals and regulatory requirements
- Ensures effective resource allocation and capacity planning to meet operational demands while maintaining compliance with quality standards
- Provides comprehensive QA oversight and support for manufacturing operations and associated support functions such as Process Science Engineering Science Process Engineering Validation and Automation
- Ensures the quality assurance (QA) review and approval of exceptions and CAPAs while also facilitating the timely review and approval of process performance qualification (PPQ) protocols and reports continuous process monitoring protocols and reports risk assessments changeover processes equipment release and sample plans. Additionally approves drug substance (DS) retain requests as necessary
- Establishes robust QA processes to ensure adherence to cGMP regulations and alignment with client Quality Agreements
- Assesses the impact of system and process modifications ensuring effective oversight of change management processes to maintain validated states of manufacturing systems throughout their lifecycle
- Ensures Quality batch Disposition and collaborates with partners external stakeholders and other parts in the Quality function as needed
- Oversees validation activities during startup and commercial operations to ensure compliance with regulatory standards
- Approves critical lifecycle documentation including risk assessments product/process/equipment specifications functional specifications traceability matrices qualification protocols validation plans and validation summary reports
- Ensures documentation is accurate complete and compliant with regulatory expectations to support operational readiness
- Drives a robust Quality Culture across the site by fostering collaboration within the operational peer network and embedding quality principles into daily activities
- Acts as a key advocate for quality excellence across all levels of the organization
- Generates reviews and approves QA documentation procedures and processes to support operational readiness objectives in a CGMP-regulated facility
- Oversees the preparation of trend reports for process performance and environmental monitoring to ensure continuous improvement.
- Collaborates with other FUJIFILM Biotechnologies sites to harmonize processes share best practices and maximize efficiency across the network
- Actively participates in cross-functional initiatives to align global quality strategies
- Partners with internal stakeholders and clients to define functional specifications and process together with monitoring of Quality metrics for GMP Operations
- Works with internal teams and clients to manage data used for continuous manufacturing validation activities continuous improvement initiatives and regulatory commitments
- Drives the teams efforts in curating critical knowledge and developing best practices in Quality and Operations disciplines
- Serves as a key stakeholder in business development efforts while defining the future large-scale operations model including contributing to the sites digital roadmap for GxP process data management
- Mentors employees and oversees their development to ensure the team is positioned for long-term growth and success
- Partners with HR Talent Acquisition and other stakeholders to attract top talent while developing effective retention strategies
- Evaluates team performance regularly implements measures to improve productivity and engagement levels and identifies high-potential employees for further development opportunities
- 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
- Bachelors degree in engineering life sciences with 13 years of related experience OR
- Masters degree in engineering life sciences with 11 years of related experience OR
- Ph.D. in engineering life sciences with 9 years of related experience
- 10 years of people management leadership and team management experience
- Experience in cGMP manufacturing operations and/or Quality role in an FDA/EMA regulated facility.
- Experience and working knowledge of ICHQ7 and 21CFR part 820 and part 11 and EU GMP vol 4 including ALCOA guidelines.
- Experience collaborating and interacting with a global team.
- Training and/or familiarity with Quality Risk Management principles
Preferred Requirements
10 years experience in a GMP quality assurance (QA) role in commercial biopharmaceutical facility
Experience in other GMP functions (manufacturing MSAT Engineering)
Strong track record of driving operational excellence
Experience with the following processes such asTrackWise Veeva SAP Syncade
Working & Physical Conditions
PHYSICAL DEMANDS
Will work in environment which may necessitate respiratory protection x No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. x No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. x No Yes
Ability to discern audible cues. No x Yes
Ability to inspect or perform a task with 20/20 corrected vision visual acuity including distinguishing color. x No Yes
Ability to ascend or descend ladders scaffolding ramps etc. x No Yes
Ability to stand for prolonged periods of time. No x Yes Daily for up to 120 minutes (If yes may specify frequency/duration: up tominutes)
Ability to sit for prolonged periods of time. No x Yes Daily for up to 120 minutes (If yes may specify frequency/duration: up tominutes)
Ability to conduct activities using repetitive motions that include wrists hands and/or fingers. No x Yes
Ability to operate machinery and/or power tools. x No Yes
Ability to conduct work that includes moving objects up to X pounds. No x Yes If yes x 10 lbs. 33 lbs.
Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions. x No Yes
ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments x No Yes Range (If yes specify approximate temperature ranges.)
Will work in outdoor elements such as precipitation and wind. x No Yes
Will work in small and/or enclosed spaces. x No Yes Will work in heights greater than 4 feet. x No Yes
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 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.
Job Location:
Monthly Salary:
Not Disclosed
Posted on:
15 hours ago
Vacancies:
1 Vacancy
