We are looking for a well-established expert in the area of Quality, with emphasis on Quality Control and with strong scientific credentials who are aligned with our noble mission. The candidate should be driven to attain the highest standards of success with integrity.
The role of the Head of Quality will be an integral part of our organization. This contributor should apply extensive organizational skills and knowledge both as an individual and as part of a team, to lead both QC and QA departments of the organization as well as meeting regulatory requirements (in terms of standards and regulations) and QC requirements (in terms of good engineering). The Head of Quality role is expected to provide significant guidance as well as hands on support in the development of new documents, procedures, and changes to existing procedures, processes, plans, and other quality system documentation. The successful candidate will be required to support the creation of regulatory submissions [CMC package for IND submission, FDA inspection of the manufacturing facility etc) and/or updating documents and procedures as well as actively participate in the creation, implementation and continuous improvement of the quality system including developing, maintaining and reporting quality system metrics. The Head of Quality role would manage changes to documentation/PLM(Product lifecycle management) system. New documents and document changes are required to be entered into the documentation system, approvals are obtained, and documents are distributed in a controlled manner.
Applicable data/records are to be processed into a documentation system on a daily basis and reports are generated. All documents must be stored and organized to facilitate efficient and timely retrieval via the documentation systemMAJOR RESPONSIBILITIES:
- Responsible for QC testing methods tech transfer, qualification, and validation.
- Accountable for clinical product release.
- Responsible for review and approval of QA and QC SOPs, Formats, Attachments, Annexures and Templates for supporting RnD, QC and GMP lab work.
- Responsible for review and approval of all QA apex documents like Quality Manual, Site Master File, Validation Master File.
- Candidate should have good working knowledge of GMP as per FDA, EMA and Indian Regulatory Guidelines in Cell and Gene Therapy.
- Responsible for assisting in preparation and review of R&D, QC and GMP SOPs, protocols, reports, justifications, etc.
- Responsible for reviewing and archival of Log Books and Lab Note Books, etc.
- Familiarity with eQMS is required.
- Responsible for leading in preparation and review of installation qualification, operation qualification and performance verification documents for all labs, including GMP suits.
- Responsible for review and archival of batch manufacturing records, in-house CoAs, etc.
- Responsible for arranging the trainings, evaluation and keeping records of the trainings.
- Responsible for maintaining records of MSDS, product sheets, CoAs, etc.
- Responsible for maintaining equipment labels, tracking the PV/calibration schedules.
- Implementation of Safety Practices with appropriate use of personal protective equipment’s.
- Creating awareness for GMP, GLP and GDP. Arranging internal audits for good lab practices.
- Responsible for overviewing data logger system for temperature and gas sensitive equipment.
- Responsible for preparing quality agreement, vendor evaluation, towards GMP work.
- Responsible for keeping records of CDAs, MTAs, etc.
- Ensure integrity of all QA and QC files for the purpose of efficient and timely retrieval of generated documents
- Perform audits of the documentation system to identify any documents that need to be written, revised, or obsolete, work with appropriate staff to assure relevant documents reside in appropriate locations.
- Solve administrative issues such as lock-outs, training new employees on the system, assuring employees have appropriate access to the system
- Write audit reports, review /edit documentation, scribe during FDA audits and provide front room/back-room support during 3rd party audits.
- Will direct reviews related to appropriate parties per review procedure
- Lead deviations investigations resulting in corrective and preventive action
- Provide guidance and instruction to engineering and manufacturing personnel on quality system/quality assurance/regulatory requirements and documentation
- Will actively participate in the maintenance and continuous improvement of the quality system.
- Participation in Installation activities instrument Qualification in co-ordination with user as applicable.
- Participation in external seminar for Quality Practices
- Scientific knowledge of QC assays in cell and gene therapy space
- GMP, GLP and GDP compliance
- Quality System Management
- Product release process
The candidate MUST have the following skills without which the application will not be reviewed:
- Has significant experience in leading quality department in industrial biotechnology organization
- Implemented Quality Management System for GMP Manufacturing Facility
- Good understanding of biologics and cell-based products
The candidate must be able to work collectively in a team-spirit dedicated to attain the highest standards of science and medicine. Candidate should be able to work with a global team across US/India time zones; cultural differences; multi-tasking; results-oriented; experienced in working at small biotech start up environment; good communication skills; highest levels of integrity; and able to deliver results based upon milestones.
Candidate MUST have the minimum level of Masters (post-graduate) in Pharmacy / Biotechnology / Microbiology / Life Sciences or any other related Biology field) specializing in the areas QC, QA and Regulatory, with focus on GxP compliance, and product release.
MINIMUM YEARS OF EXPERIENCE IN THE AREA:
Candidate must have worked for at least 15 years in the areas of Quality (both QC and QA) with significant experience in implementation of quality management systems in Biologics, Biosimilars or Cell-based product manufacturing company....