SUMMARY:
Zydus Therapeutics, Inc. is a research organization with a focus on providing quality and safe clinical research and development. Our parent company, Zydus Lifesciences, has a large presence in global markets, including relationships with many top tier international pharmaceutical companies. Based on a manufacturing and development history that spans over 50 years, it is the 4th largest pharmaceutical company in India. Zydus Lifesciences has expanded into development of novel therapeutics and new chemical entities.
RESPONSIBILITIES:
- Quality Compliance:
- Deviation Management:
- Change Management:
- SOP Management:
- Audit and Inspection Readiness:
- CAPA Management:
- Training Management:
- Vendor Evaluation:
- Computer and Electronic systems:
- Any other responsibilities as assigned.
Head a team of quality compliance reviewers involved in quality compliance of all the Zydus Therapeutics Ltd clinical trials executed across geographies.
Escalate trial related scientific misconducts, frauds and data integrity issues, if any to senior leadership.
Responsible for taking key trial related quality decisions on vendor qualification or disqualification site selection and trial specific data management.
Participate in key strategic decision making on Clinical trials and resourcing.
Responsible for Quality Management set up of Clinical Research unit.
Responsible for planning and managing Quality Compliance programs of global clinical Trials of Zydus Therapeutics Phase I, Phase II, Phase III and Phase IV in various therapeutic area.
Plan, strategize, conduct and oversee the quality compliance activities like trial specific quality reviews at Investigators site, CRO and vendors in order to check whether Clinical trial and related activities are conducted as per the Clinical study protocol, ICH GCP, SOPs and applicable regulatory requirements.
Plan and release annual Quality Compliance Plan for review of Quality systems at Zydus Therapeutics for example SOP system, Training system, HR system, Data Privacy & protection and Contract Management.
Conduct, oversee and delegate the quality compliance activities within QC team including review of site activation check list, Trial master file review, review of compliance to study specific documents like Protocol, Project Management Plan, Clinical monitoring plan, Quality Compliance plan and safety Management Plan.
Responsible for reviewing project specific clinical research documents like Protocol, Investigators Brochure, Data safety update report, Project Management Plan, Clinical Monitoring Plan, Quality Compliance Plan and Clinical study Report from quality compliance stand point for each of the global clinical trial of Zydus Therapeutics.
Responsible for Identification and facilitation of systemic and trial specific protocol violations and deviations and support teams on documentation and CAPA Management.
Responsible for Support and facilitation of Change management within Zydus therapeutics team in terms of change in computer application, vendor, process and procedures.
Responsible for driving the creation, review and approval of standard operating procedures, standard work instructions and allied quality documents within Zydus therapeutics.
Conduct the gap analysis and identify the need to create new standard operating procedure and standard work instructions.
Drive periodic revision of standard operating procedures and policies.
Single point of contact on creation and revision of system and project specific quality documents.
Drive creation and review of project specific quality documents like quality Compliance plan and standard work instructions.
Prepare the team and support the Health authority regulatory inspections at Zydus Therapeutics at site, vendor and Zydus office.
Prepare and support Zydus Therapeutics project teams for Quality assurance audits.
Support and review Zydus therapeutics Clinical operations team and Project Management team to develop Corrective and Preventive action(CAPA) on internal audits and regulatory inspection findings, if any.
Responsible for identifying and driving training program of Zydus Therapeutic team across geographies.
Responsible for creation of Induction plan of new joiners, ensure and review the induction training and sign off of new joiner.
Responsible for creation of yearly training calendar for Zydus Therapeutic team. Conduct and facilitate trainings on regulations, SOPs and plans, as applicable.
Responsible for review of Training files of all the employees of Zydus Therapeutic Team on six monthly basis.
Conduct/facilitate GCP workshops within the ZTI team and for vendors and CRO, as applicable.
Responsible for conducting and overseeing the evaluation and qualification of vendors across geographies comprising of Contract Research Organization, Clinical Data Management, Clinical Laboratory, Medical Writing and Regulatory submission.
Conduct periodic assessment of vendors.
Responsible for Maintenance of central repository of vendors.
Participate in periodic calls with vendors as point of contact on study/project quality.
Responsible for identification of risk on various clinical trials of Zydus Therapeutics internally and externally with vendors and facilitate the risk mitigations.
Drive Escalation management within Clinical Trial vendors on trial specific issues for various clinical trials at Zydus Therapeutic.
Identify the need of digitalization and drive the digitalization internally within Zydus Therapeutics Ltd in collaboration with vendor so that the digitalized process meets the regulatory requirements.
Review of computer system validation of electronic systems process and documents used internally within Zydus Therapeutics and by vendors.
QUALIFICATIONS – SKILLS & REQUIREMENTS:
- Significant understanding of quality compliance requirements in the United States and international locations.
- Established proficiency in tools and technology common to clinical operations (e.g., Microsoft Office (i.e., Word, Excel, and PowerPoint), Adobe Acrobat, workspace videoconference and chat systems (i.e., Microsoft Teams, Zoom, WebEx), clinical trial management systems, various electronic data capture systems, etc.).
- Analytical thinker with excellent problem-solving skills.
- Excellent planning, organization, and leadership skills.
- Excellent verbal and written communication skills.
- English is the predominant language for most regulatory documents handled by this position; should be able to demonstrate good verbal and written English.
- Must be sensitive to cultural distinctions with an ability to form cross-cultural professional relationships.
EDUCATION & EXPERIENCE:
- Bachelors or Masters in a life-sciences discipline with 10+ years progressive experience in clinical drug/device development working in a project oriented international matrix organization.
- Professional experience in a multi-cultural, multi-national environment.
TRAVEL:
- The position will require domestic and international travel (up to 15%).