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Head Quality Review, Clinical Development

4 months ago

Bengaluru, India Syngene Full time

JOB DESCRIPTION

Designation: Head Quality Review, Clinical Development

Job Location: Semicon Park, Bengaluru

Reporting to: Operating Unit Head, Clinical Development

Job Grade: 5-II/5-I

Company Overview

International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene’s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development, and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.

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Mandatory expectation for all roles as per Syngene safety guidelines

Overall adherence to safe practices and procedures of oneself and the teams aligned. Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards. Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene’ s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time.

Role Summary

The Head of Quality Review is a pivotal role within the Clinical Development Operating Unit, responsible for overseeing and enhancing the quality standards across all departments. Clinical development OU operates in BA/BE studies, patient clinical trials, central clinical lab to support clinical research, small and large molecule bioanalytical lab. The primary purpose of this role is to ensure that the OU consistently meets or exceeds regulatory and internal quality benchmarks. This is achieved by owning and driving the quality metrics, leading process/SOP improvements, and ensuring the OU is anytime audit ready.

Key Result Areas:

Develop and Maintain Quality Metrics: Create and sustain comprehensive metrics that assess performance and compliance across all divisions, ensuring that the organization adheres to internal and regulatory standards. Develop and Maintain Quality Metrics : Create and sustain comprehensive metrics that assess performance and compliance across all divisions, ensuring that the organization adheres to internal and regulatory standards. Enhance SOPs and Processes : Lead initiatives to refine standard operating procedures (SOPs) and workflows, enhancing operational efficiency and regulatory compliance. Lead Regulatory Audits: Guide the organization through various audits and inspections, including internal, customer-based, and regulatory audits, ensuring all activities comply with applicable laws and standards. Collaboration and Error Minimization : Work closely with section heads and the Quality Assurance (QA) team to identify and reduce errors, fostering a culture of continuous improvement and compliance. Strategic Feedback and Communication: Provide detailed trend analyses and feedback on compliance and quality issues to department heads and senior management, keeping them informed of ongoing quality status and areas for improvement. Manage Quality Issues : Collaborate with operational teams to address, escalate, and resolve quality issues, assisting in the development and implementation of corrective action plans. Audit Preparedness: Maintain a state of "anytime audit readiness" by implementing robust quality control systems and conducting regular internal reviews. Drive Continuous Improvement : Lead efforts in process simplification, and other quality improvement initiatives, aiming to achieve and sustain world-class standards in both leading and lagging indicators of Quality KPIs. Quality Review Leadership : Head quality review groups to ensure high-quality outputs for clinical research activities, aligning team and cross-functional efforts to meet and exceed established quality standards.

Role-specific

BA/BE: Section

Quality Control Plan Execution: Develop and oversee the implementation of the Quality Control Review Plan (QC) for each study, ensuring meticulous execution and adherence to standards. Monitoring and Oversight: Monitor protocol compliance and documentation, conduct clinical study conduct reviews, and ensure the integrity of study processes. Quality Control Processes Definition: Establish Quality Control Review processes to: Manage the review and approval of draft source documents, ensuring alignment with the protocol, HPU SOPs, ICH GCP (E6), and other relevant regulatory guidelines. Verify screening charts for accuracy of Inclusion/Exclusion criteria, informed consent form (ICF) documentation processes, and Investigator/Sub-investigator review activities. Ensure comprehensive review of all source documents against quality control standards as outlined in the QC Plan. Conduct reviews of study day records to confirm data completeness, consistency with protocol requirements, and adherence to good documentation practices and ALCOA+ principles. Documentation and Compliance: Ensure that the Quality Control Review process is thoroughly documented, with all QC observations and protocol deviations addressed and resolved in a timely manner before data entry. Verification and Reporting: Lead the Quality Control Review team in verifying source data against electronic Case Report Forms as stipulated in the QC Plan. Communicate any issues or deviations in protocol to clients, the Principal Investigator (PI), and the VP & OU Head of Clinical Development. Client and Team Interaction: Meet regularly with clients to discuss protocol adherence, address any deviations, and report on consistent QC observations. Resolution Deadlines: Establish and enforce deadlines for resolving queries, ensuring prompt compliance. Regulatory Documentation Review: Oversee the QC review of the Regulatory/TMF Binder at the conclusion of the study, ensuring readiness for archiving. Error Analysis and Liaison Duties: Analyze the nature and cause of errors to identify areas for improvement within departmental processes and systems. Serve as a liaison between staff and management to discuss error trends and areas of concern.

Bioanalytical Laboratory operations Section activities

Data Integrity and Review : Conduct comprehensive checks on method development, validation, sample analysis, concentration data, and database locks to ensure data integrity across all studies. Document Review for Compliance : Scrutinize all study documents to confirm readiness for Quality Assurance Unit (QAU) review, adhering to planned timelines for each review process. Collaborative Problem Solving : Engage directly with the study director to discuss observations, propose solutions, and reach consensus on Corrective and Preventive Actions (CAPA). Audit Support: Provide robust support during all QAU, sponsor, and regulatory audits, ensuring all practices meet required standards. Facility Oversight : Perform routine facility inspections to maintain the facility’s condition and ensure that all related documentation is up to date. Quality Control of Laboratory Practices : Regularly review laboratory logbooks and check the calibration and validation status of equipment to maintain operational standards. Data Trend Analysis : Analyze Quality Control observations monthly to support the Head of Department (HoD) in driving quality transformation initiatives. Leadership in Quality Assurance: Spearhead the Quality Circle initiative, providing weekly updates to the HoD on progress and outcomes. Resource Allocation : Efficiently allocate staff for study reviews to ensure optimal team performance and study coverage. Standard Operating Procedures Support : Assist in the development and revision of Standard Operating Procedures (SOPs), participating actively in their preparation. Efficient Data Review : Manage the simultaneous review of multiple studies’ data, ensuring an efficient and effective process

Central laboratory section activities

Comprehensive Quality Checks : Oversee Pre-Analytical, Analytical, and Post-Analytical activities, ensuring all procedures adhere to the established Quality Control Standard Operating Procedures (QC SOP). Data Entry Verification : Ensure that all manually transcribed data is accurately captured and corresponds with the respective worksheets, guaranteeing data integrity. Logbook Management : Maintain strict control over logbook entries to ensure all records are legible and properly managed within the Clinical Laboratory (CLAB). Ensure that logbooks are maintained and controlled according to laboratory standards. Quality Control Data Review : Conduct daily reviews of Quality Control data across multiple disciplines, including Clinical Biochemistry, Hematology, Serology, Coagulation, and Clinical Pathology, to ensure consistency and accuracy. Non-Conformance (NC) Logbook Implementation : Manage the Non-Conformance logbook, identifying areas for improvement and implementing necessary changes to enhance laboratory processes. Instrument Maintenance and Calibration : Maintain rigorous follow-up of instrument preventive maintenance schedules and calibration records, ensuring all equipment operates according to industry standards and regulatory requirements.

Clinical trials, data management, statistics, and pharmacy section activities

Internal System Reviews : Conduct internal reviews of the Clinical Trial Management department and Syngene Clinical Supply Unit (SCSU) to ensure compliance with Standard Operating Procedures, Good Clinical Practice, and regulatory requirements in line with the Quality Management Plan. SOP and Training Review Coordination : Oversee the review of Standard Operating Procedures (SOPs) and assess the need for updates in training binders, ensuring all documentation supports current practices and regulatory standards. Quality Issue Reporting : Promptly inform the Department Head or designated representative about significant quality issues. Ensure reporting aligns with established operating procedures or work instructions, with a focus on patient safety, regulatory compliance, and data integrity. Syngene Clinical Supply Unit Quality Checks : Perform comprehensive quality checks within the Syngene Clinical Supply Unit as part of the Clinical Trial Management oversight to uphold system integrity. Database and Code Quality Control : Execute quality control checks on databases and associated programs or codes as specified in the Quality Control plan to maintain accuracy and functionality

As a Syngene leader:

Champion effective Environment, Occupational Health, Safety, and Sustainability (EHSS) practices for the company, and oversee compliance with those practices within the IDD team. Play an active leadership role in monitoring and verifying safety performance through GEMBA walks and other safety-led activities. Foster a corporate culture that promotes an environment, occupational health, safety and sustainability (EHSS) mindset as well as the highest standards of quality, integrity and compliance. Put people at the heart of Syngene’s success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning, and talent retention as a priority.

Education and Experience

Education:  M. Pharm, MSc – Post graduate degree in life sciences, Minimum required. PhD will be added advantage.

Industry Experience:  At least 15 years’ experience in working in GxP and compliance environment. Deep understanding of process and compliance in GxP environment.

People leadership experience:  At least 7 years’ experience in leading teams directly and working with cross functional teams in a metrics organization.

International exposure and experience : Not required, but desirable if any.

Other competencies required for the role

Excellent people skills with extensive experience in leading change, and a proven ability to instill a culture of collaboration. Keen interest in scientific innovation in a commercial setting. Strong customer and service delivery mindset with a proven track record in delivering business growth. High degree of results orientation with a track record of growth and delivering against targets. Well networked and strong industry knowledge. Confident and well-practiced language and interpersonal skills Impeccable ethics and integrity along with an exposure to a multi-cultural work environment.

Equal Opportunity Employer

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.