Clinical Quality and Compliance Associate Manager

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long term commitment to bring high quality affordable biosimilars to patients all over the globe. We have proven end to end expertise from clone development, manufacturing, clinical development, regulatory approvals to commercialization in developed and emerging markets.

We are seeking a candidate at our headquarters in Bangalore, India to support our clinical quality and compliance function within the Clinical Development and Medical Affairs organization. Reporting to the Head Clinical Quality and Compliance, Senior Clinical Quality and Compliance Specialist will support in continuous improvement of processes and methods established to ensure the quality of studies conducted by Clinical Development and Medical Affairs.

Role & responsibilities :

Develops and maintains ICH-GCP compliant processes to ensure quality in the clinical trials conducted

. • Actively leads or assists activities in the areas of Internal Quality Audits, CAPA (Corrective Action and Preventive Action), Quality Management Reviews, and Quality Audits.

• Leads quality review activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines and agency regulations.
• Leads or assists with identifying non-conformances with requirements.

• Provides suitable recommendations and facilitates ongoing quality improvements while maintaining compliance with applicable study protocols, and standards.

• Supports in conducting vendor audits and works with vendors in eliminating problems via root cause analysis techniques, to ensure that product quality continuously improves.

• Performs internal quality reviews of Trial Master Files.

• Performs internal quality reviews during preparation of study documents e.g. Protocols, IBs, ICFs.

• Performs Sponsor quality visits at Sites as well as CROs (clinical, analytical PK, immunogenicity etc.) are conducted based on requirements.

• Supports in vendor selection, to evaluate vendors and ensure they have enough capacity and capability to deliver quality products and services on time and in compliance with regulations.

• Performs Risk assessment/analysis of internal systems and processes.

• Supports in GAP analysis (either internally or through external consultant) as and when required for Clinical Development.

• Follows Change control and Change management system as per company procedures.

• Performs other related duties as assigned.

• Performs following activities of Training Department Coordinator, but not limited to, for Clinical Development & Medical Affairs (CDMA): * Create / upload training material / course and questionnaires for the department * Publish assessment questionnaire for the department

* Schedule classroom/self-trainings which include CD SOPs/WGDs and Technical trainings in LMS/LMExcellence applicable for CDMA and/or other cross functional teams * Mark attendance for training attendees and Certifying trainings (in case there is no trainer assigned) * Review/Generate training reports, CV, JD for self and other users within the department (if required) * Ensure/Create Master Job Descriptions for all CD roles

• Supports in compliance of pharmacovigilance and/or medical affairs process and systems as applicable • Develops corrective action plans and defines de-risking strategies to mitigate the risks and ensure business continuity for CDMA.

Biocon Biologics is an Equal Opportunity, EEO / Affirmative Action Employer committed to excellence through diversity. All qualified applicants will receive consideration for employment without regard to, and no employee shall be discriminated against because of their race, color, religion, age, sex (including pregnancy), national origin, disability, genetic information, status as a protected veteran or any other characteristic protected by applicable federal, state or local law.