Local Quality & Study Specialist at F. Hoffmann-La Roche Ltd - Poland

Dhaka, Dhaka Division, Bangladesh -

Full Time

Start Date

Immediate

Expiry Date

12 Jun, 26

Salary

0.0

Posted On

14 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

QMS Implementation, Medical Compliance, Risk Management, Quality Monitoring, Audit Support, CAPA Management, ICH GCP, GVP, GPP, Study Execution, RWE Management, Vendor Oversight, Leadership, Communication, Evidence Generation

Industry

Biotechnology Research

Description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position A hybrid medical compliance role combining Local Quality Responsible (LQR) and Study Specialist for ensuring compliance strategies for affiliate medical and clinical operation function. LQR - Responsible for implementing the Affiliate Quality Management System (QMS), ensuring local medical compliance, and supporting the CMD in maintaining the affiliate License To Operate (LTO). Accountable for medical compliance reporting and inspection readiness, adhering to both local regulations and global standards. Study Specialist - Responsible for execution of Investigator Initiated Studies (IIS) and manage secondary data use Real World Evidence activities (RWE), and/or the country management of global studies ensuring the effective and efficient delivery of all operational aspects in accordance with the appropriate quality standards including ICH/GCP and GVPs/GPPs. What you will be working on: As the Local Quality & Study Responsible, you will be working both in in-country cross functional and cross border collaborations, to realize and scale country outcomes. Following VACC Principles—Visionary, Architect, Coach, and Catalyst—define a creative leadership approach to shape the Quality vision, design the QMS, build skills, and connect strategy with the QMS to accelerate business outcomes while maintaining high standards. Your key responsibilities include but are not limited to: Local Quality Responsible: 50% QMS Implementation: Ensures effective local QMS framework implementation, prioritizing simplification, resource efficiency, and timely escalation of issues to Global (PDQ). Medical Compliance (LTO CORE): Leads Affiliate Medical Compliance Oversight and delegated Local Medical Compliance responsibilities from the CMD. Risk & Opportunity Management: Proactively identifies, manages, and escalates Medical Compliance risks and opportunities at the local level. Quality Monitoring: Designs and executes affiliate quality monitoring strategies to mitigate risks in collaboration with local and global stakeholders. Audit & Inspection Support: Coordinates preparation, execution, and CAPA responses for audits/inspections impacting QMS and GCP/GVP regulatory compliance. MAP Leadership: Acts as the affiliate lead and global point of contact to ensure Market Research and Patient Support Programs meet quality standards. Study Specialist: 50% Ensures adherence to guidelines (ICH GCP/GVP/GPP), regulations, and Roche procedures while maintaining constant inspection readiness and finalizing all CAPAs. Accountable for tracking HA/EC approvals and managing study plans, systems, budgets, documentation, metrics, and risk management (RBQM). Oversees vendor deliverables and performance, ensuring adherence to timelines, quality standards, and training while resolving systematic issues. Supervises study activities from site activation to closure, including monitoring, training, and managing drug supply resolution. Manages additional responsibilities for multi-country studies in accordance with Roche processes and policies. Who you are: You are a qualified medical affairs professional with growth and value creation mindset. With your Visionary, Architect, Catalyst & Coach (VACC) leadership capabilities and commitments you are able to create strong collaborations to drive change for better patient outcomes. You have: Qualification: Life Science degree Experience: Demonstrated experience and expertise gained ideally within the medical affairs or clinical functions. Outstanding Communication: Effectively communicate scientific information with impact and influence, empathetically tailored to external stakeholders. Subject Matter Expertise: Skilled in evidence generation (clinical trials, Investigator Initiated study (IIS), Real World Evidence (RWE) programs), scientific and publication management. Customer-Centricity: Co-create solutions addressing customer needs to transform clinical practice. Entrepreneurial Mindset: Identify opportunities, experiment, take risks, and disrupt the status quo. Prioritization Skill: Focus and prioritize in uncertain environments, manage budget and multiple projects efficiently. Borderless Collaboration: Work closely with countries/communities/teams, share and learn collectively to upscale Ecosystem Solutions. System Thinking: Build trusted relationships, be authentically courageous This role may require domestic/international travel and is only open to candidates that have full eligibility to live and work in Bangladesh. Roche has a dedicated in-house Talent Acquisition team. We do not accept unsolicited resumes or enquiries from recruitment agencies. What we offer Roche offers rewarding growth opportunities, a competitive remuneration package and a collaborative culture where people are united in purpose and will stretch you to be brave, speak up and think differently. Feel empowered to deliver meaningful outcomes, supported by accessible and inspiring leaders. Roche encourages a high-performance culture where you are empowered and trusted to make decisions. We strive for excellence and extraordinary results and take a genuine interest in our people and their well-being, and our patients. Take pride in knowing you can make a difference to millions of patients worldwide in developing diagnostics and treatments for oncology, neuroscience, inflammation, immunology, ophthalmology, rare diseases, respiratory disease and diabetes. We are committed to providing an inclusive, safe, secure and healthy workplace, and to minimise any such impacts to our employees, customers and the community. We welcome applications from all people and encourage you to advise of any individual circumstances that may require consideration. Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.

Responsibilities

This role involves implementing the Affiliate Quality Management System (QMS), ensuring local medical compliance, and leading audit/inspection readiness activities (Local Quality Responsible, 50%). Additionally, the specialist manages the execution of Investigator Initiated Studies (IIS) and Real World Evidence (RWE) activities, overseeing operational aspects according to quality standards (Study Specialist, 50%).