About Stelis
Stelis Biopharma is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), with a complete and integrated end-to-end offering. We work side-by-side with our clients as true partners, with customer-centric collaboration and communication. We provide world-class process development and manufacturing infrastructure for both drug substance (mammalian and microbial-based therapeutic proteins and viral vectors) and drug product (lyophilized vials, liquid vials, pre-filled syringes, cartridges and devices). Our highly experienced quality and regulatory personnel help us meet global quality standards, ensure compliance and guide our clients through the regulatory approval process. Our three state of the art facilities are staffed by around 700 highly talented professionals. As the most agile CDMO in the industry, Stelis Biopharma is a trusted CDMO partner of choice. To learn more, visit www.stelis.com
Purpose:
The role will be responsible for all Quality Control procedures and systems and will manage Analytical, Bioassay, QMS, Microbiology, and GMP laboratories with oversight to technology transfers, qualification/validation of assays and QC activities for product release. Plays a pivotal role in driving the Quality culture in the organization.
Primary responsibilities
Quality Control planning:
- Collaborate with Process Development team and Clients on development and transfer of plan for methods and test procedures
- Ensure effective communication and timely update on analysis to all the stakeholders
- Maintain awareness and training of new and current guidelines that governs the development and manufacturing and implement the changes
- Collaborate with cross functional heads and ensure anytime readiness for customer and regulatory inspections
- Plan and work effectively to consistently achieve product release testing cycle time targets and meet project due dates and deliverables
Operations:
- Responsible for compliance of the QC testing data
- Support regulatory fillings including reviewing relevant QC sections
- Ensure that the committed QC Turnaround time (TAT) for testing is met
- Ensure Investigation and closure of laboratory incident reports, as applicable
- Follow all quality control activities in accordance with Quality procedures, specifications, and SOP requirements
- To ensure that all activities are performed in accordance with cGMP, SOPs, Health and Safety policies
- Lead and collaborate with cross functional teams in operational review meetings on a day-to-day basis
- Responsible for the compliance of site quality control laboratory operations
Resource Management:
- Plan and optimize existing resources and organize them. Provide applicable MIS (Quality Measurement reports) and contribute to the periodic management reviews in order to ensure that business / regulatory needs are met
Audits, Compliance & Risk Management:
- Ensure establishment and maintenance of cGMP at the site through periodic audits
- Ensure periodic internal audits are conducted and systems are improved based on risks identified
- Ensure all time readiness of site for various regulatory & customer audits
- Assure compliance with International regulations including the contribution to compilation of dossiers and submissions
- Conduct supplier and subcontractor audits and prepare related reports as per the schedule
Training:
- Identify training needs to stay updated with regulatory expectations, as well as to demonstrate high level of technical competence with customers
- Deploy training modules around GxP, technical skills, leadership skills, Operational Excellence and quality management
Team Management:
- Build and develop the team and create effective succession planning for critical roles in the function
- Ensure resource planning, provide direction and guidance to the team, manage, motivate, coach and mentor direct reports, to higher levels of management capability
Key requirements
- Post-Graduation in Biochemistry or Microbiology or a related field; or Ph.D. preferred
- 16+ years of relevant experience in the biopharmaceutical/pharmaceutical industry managing sterile operations, including 8-10 years of team management experience
- In depth understanding of GCP, GLP and GMP requirements
- Excellent communications and Leadership Skills, Time Management, Execution Orientation, Achievement Orientation
- Demonstrated capabilities in coaching and developing teams, collaborating with cross-functional teams and abilities to nurture Quality mindset in the site
- Excellent written and verbal communication skills with strong technical writing skills
Reference code: SQCH01