Job Description

Job Overview:

This role serves as the Quality Responsible Person (RP), ensuring that operations, infrastructure, and storage conditions maintain product quality throughout its lifecycle, in compliance with GDP regulations and principals’ requirements.

The role also oversees the development and continuous improvement of the Compliance Program, ensuring adherence to anti-bribery and anti-corruption laws (UK Bribery Act and U.S. FCPA), contractual obligations, and all applicable regulatory requirements to maintain the organization’s license to operate and compliance with principal contract terms.

Key Responsibilities:

Quality Management System standard

• Establish, implement, and maintain a GDP-compliant Quality Management System (QMS) governing the storage and distribution of life science and medical products and equipment, ensuring quality, integrity, traceability, and patient safety throughout the supply chain.
• Define and enforce controlled processes (SOPs, work instructions, quality checkpoints, and records) across all logistics operations, including procurement, receipt, storage, inventory control, picking, packing, dispatch, transportation, delivery, and post-delivery activities.
• Own and maintain key GDP quality system elements, including document and record control, data integrity, change control, Internal audit and self-inspection, deviations, CAPA, quality risk management, validation/qualification, calibration, preventive maintenance, and temperature monitoring.
• Manage product-related quality events, including complaints, returns, recalls, investigations, and product disposition decisions, ensuring timely resolution and compliant documentation.
• Qualify and oversee outsourced activities and service providers, ensuring appropriate approval, establishment of service level agreement, performance monitoring, and ongoing compliance.
• Conduct management reviews and drive continuous improvement of the QMS based on quality metrics, risks, audit outcomes, deviations, and CAPA effectiveness.
• Review quality agreements with business partners, assess their due diligence questionnaires, address raised concerns, and communicate clear quality system requirements to relevant operational and business units.
• Ensure compliance with principal Quality Agreements and contractual quality requirements throughout the contract, including reporting and communication of change management, product market release, deviation, and investigation.
• Maintain robust supply chain security controls to prevent contamination, mix-ups, falsification, tampering, theft, or unauthorized access.
• Ensure a proactive approach to comply with emerging laws, regulations, industry trends, and evolving requirements from business partners, customers, and other relevant stakeholders.

Ethics and Compliance standard

• Develop, implement, and maintain an effective Compliance Program aligned with applicable global and local laws, including anti-bribery, anti-corruption (UK Bribery Act, U.S. FCPA), and ethical business conduct requirements.
• Serve as a focal point of contact to business partners and address their due diligence and ensure compliance with the principal contract terms is maintained through the life cycle, including but not limited to Anti-bribery provisions, books and records, internal controls, data protection and privacy, third party, trade sanctions.
• Support the business divisions for all compliance audits and assessments, and ensure timely closure of reported deviations with the establishment of effective CAPA measures.
• Establish and maintain compliance policies and standards, including Code of Conduct, conflict of interest, anti-bribery/anti-corruption, gifts & hospitality, and third-party integrity requirements.
• Identify, assess, and mitigate compliance risks, implement appropriate policies, controls, and monitor mechanisms across commercial and operational activities, and support execution for promotional and non-promotional HCPs and HCOs interaction activities.
• Promote compliance awareness by ensuring appropriate education, communication, and training of employees and relevant stakeholders on compliance obligations and ethical standards
• Oversee financial and operational compliance controls, including monitoring of disbursements, third-party payments, tender payments, and other high-risk transactions to ensure transparency, accuracy, and integrity of records.
• Maintain an effective speak-up and non-retaliation framework, ensuring concerns are appropriately evaluated, escalated, and addressed.
• Lead impartial compliance investigations into alleged misconduct or policy breaches, ensuring proper documentation, corrective actions, and recommendations for fair disciplinary measures where required.

Qualification & Experience:

• Bachelor’s degree in pharmacy or a scientific discipline, or relevant industry.
• Atleast 3 years of proven experience in compliance and holding relevant certification such as CCEP-I, CCEP, or CAMS
• Atleast 3 years of proven experience in maintaining ISO-accredited management systems (Quality, HSE, BCMS, etc)
• Knowledge of global compliance and ethics requirements, including anti-bribery/anti-corruption standards, the UK Bribery Act, and the U.S. FCPA.
• Ability to work effectively in a diversified and inclusive work environment.
• Strong communication skills, collaboration, and stakeholder alignment skills.