Head quality
3 weeks ago
Yapan Bio is a Biotechnology Company established to serve the rapidly expanding Custom Development and Manufacturing (CDMO) market for Vaccines and Biologics/Bio therapeutics. Yapan Bio has established state of the art facilities for process development and GMP manufacturing for human clinical studies, including both Drug Substance (DS) and Drug Product (DP), at Genome Valley in Hyderabad. The facility is built as per the quality and regulatory expectation of the global regulatory authorities. The facility includes Bio Safety Level 2+ (BSL 2+) suite to develop and manufacture high containment product classes. Yapan Bio is currently developing novel vaccines and biologics for the global innovative biotechnology companies. We are looking for talented and experienced individuals, with can do attitude, who are self starters with excellent communications & leadership skills, who enjoy working on the details without losing sight of the larger organizational goals and are adaptable to a dynamic “startup” environment, to join our team. At Yapan Bio, you will get a supportive, collaborative, and empowering work environment to make a significant impact along with ownership as we drive the growth of the company together. JOB OVERVIEW: The incumbent will be responsible for leading the overall Quality function for the organization. The Head Quality will guide and lead members of the Quality Assurance (QA) and Quality Control (QC) teams to deliver as per the corporate goals, projects, plans and timelines. This position requires demonstrated ability to work effectively as both scientific/technical and people leader, manage tasks, resolve problems and issues and drive implementation/action plans to meet objectives along with excellent interpersonal and presentation skills. The candidate should be self sufficient in planning and execution along with applying innovative thinking to improve effectiveness and efficiency of the function. A person in this role is expected to engage and interact frequently with cross functional teams, senior management, external partners/collaborators, and stakeholders. QUALIFICATION: Postgraduate or PHD in a relevant field EXPERIENCE: •20 plus years of relevant experience in large molecules/ vaccines/ biologics industry •In depth knowledge of and ability to interpret and apply GMP, GLP, EU, FDA and ICH regulations, guidelines,and best practices •Experience in planning and conducting GMP and GLP audits •Experience with regulatory inspections and inspection readiness •Experience with Quality Management Systems (e.g., documentation and record management, change control, deviations, investigations, training and CAPA programs) •Strong team player with demonstrated track record of success in a cross‐functional team and fast moving environment EXPERIENCE: •Experience in authoring and compiling data for regulatory submissions (IND etc ) •Excellent organization and planning skills •Proven ability to build, lead and grow a team of technical specialists •Strong strategic, data driven analytical skills with ability to integrate complex considerations in formulating a pragmatic approach towards problem solving •Excellent cross functional and stakeholder management skills and ability to develop strong relationships across functions, senior leaders and key stakeholders •Strong communication and interpersonal skills including ability to prepare and deliver effective presentations and provide information to influence major decisions •Must have a positive attitude and be adaptable to a dynamic “startup” environment without losing focus on business goals Key Roles/Responsibilities • Formulate compliance strategy for the company as per the global quality and regulatory expectations and provide advice for all activities and programs • Assess GMP and GLP compliance risk areas and develop and implement risk mitigation • Develop and prioritize an audit strategy for all programs • Plan and lead GMP and GLP compliance and audits to determine compliance status and identify compliance risks • Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented and documented • Manage regulatory authority inspections and the coordination of responses to resolve inspection findings if any • Lead GMP/GLP training of functional areas and develop appropriate training for personnel • Design, Develop and implement standards, policies, and procedures for GMP and GLP as per regulatory compliance, in line with client requirements • Create and Participate in quality and compliance improvement initiatives within Yapan • Provide guidance, interpretation, and information on GMP and GLP regulations, standards, and quality systems • Prepare internal Quality reports, and provide input for external partners reports and/or regulatory filings • Ensure that all necessary systems and procedures are in place to satisfy all customer requirements and audits • Undertake regular internal and process audits of the Quality Management System of the organization • Ensure ongoing compliance with the Quality Management System • Report and escalate compliance issues to management, including requests for directed audits • Introduce new systems and procedures where appropriate • Plan, Mange and implement quality control systems. • Oversee all Quality Related analysis and testing, from IPQC to final product release. • Ensure that testing are completed according to established Standard Operating Practices (SOPs), and Good Laboratory Practices (GLP) to meet the project/customer requirements. • To work with cross functional teams to develop and update work progress, instructions and processes for quality control and management. • Documentation of activities as per the established procedures and presentation of data for internal and external customers. • Ensure Calibration of analytical instruments and preparation of equipment calibration plans for analytical/QC department. • Ensure implementation of all procedures, policies, guidelines, and quality systems to support the smooth flow of operations. • Oversee trend reports, analytical data summary reports and technical documents that report the results of QC lab. • Establish specifications for conducting assays and writing standard operating procedures. • Manage, engage and interact with the relevant stakeholders for preparation and presentation of data, reports and documents in the relevant formats regularly • Guide and lead members of the team to eliver as per the corporate goals, projects, plans and timelines. • Recruit, train, grow and mentor members of the team • Represent the Quality team both internally and externally • Prepare and manage department’s operating plans and budget • Foster a safe and collaborative culture and work environment to ensure the team works together to reach their potential • Communicate openly and work to the highest levels of ethics, quality, and integrity
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