Role Objective:

A key objective of this position is to ensure the organization adheres to local and international regulatory standards, including FDA regulations, ISO standards, and other relevant legal requirements. The role is responsible for planning and conducting internal audits, monitoring regulatory changes, managing compliance risks, and ensuring that the Quality Management System (QMS) is effectively implemented and maintained. Additionally, the role will support external audits, manage corrective actions, and oversee compliance documentation.

Desired Candidate Profile:

Bachelor’s degree in life sciences, pharmacy, engineering, or a related field.
Minimum of 5 years of experience in audit and compliance within the pharmaceutical or medical device industry.
In-depth knowledge of FDA regulations, ISO standards, and international regulatory frameworks.
Proven experience in Quality Management Systems (QMS) and regulatory audits.
Strong understanding of risk management, compliance procedures, and CAPA (Corrective and Preventive Actions).
Excellent communication skills, with the ability to interact effectively across departments and teams.
Strong analytical and problem-solving skills.
Certification in auditing or compliance is preferred (e.g., ISO Lead Auditor).

Role & Responsibilities:

Ensure adherence to FDA regulations, ISO standards, and other relevant local and international laws concerning audit and compliance activities.
Monitor changes in regulatory requirements and assess their impact on the organization’s operations.
Plan, coordinate, and conduct internal audits to evaluate compliance with established policies, procedures, and regulatory requirements.
Prepare detailed audit reports, including findings, recommendations, and corrective actions.
Identify potential compliance risks related to product development, manufacturing, and distribution, and develop risk mitigation strategies.
Ensure the effective implementation of the Quality Management System (QMS) to maintain product quality and regulatory compliance.
Conduct regular reviews of QMS documentation to ensure completeness, accuracy, and up-to-date records.
Oversee the management, approval, and distribution of compliance-related documentation, such as Standard Operating Procedures (SOPs).
Develop and deliver training programs to educate employees on compliance policies, quality assurance practices, and ethical responsibilities.
Investigate compliance violations and quality issues and report them to relevant authorities in a timely manner.
Implement and monitor Corrective and Preventive Actions (CAPAs) based on audit findings, non-conformances, and external audit feedback.
Facilitate communication between various departments, including manufacturing, quality assurance, and legal, to ensure organization-wide compliance.
Prepare for and support external audits conducted by regulatory agencies and third-party auditors.
Address findings from external audits and implement necessary changes to maintain compliance.
Prepare and present compliance reports to senior management, outlining audit results, compliance status, and any improvement initiatives.
Handle market complaints and conduct thorough investigations in alignment with regulatory requirements and internal procedures.
Plan and lead management review meetings, ensuring key compliance aspects are thoroughly addressed.

Functional Skills Required:

Thorough understanding of FDA, ISO, and other relevant regulatory standards and frameworks.
Expertise in internal and external auditing processes.
Experience in managing Quality Management Systems (QMS) and regulatory compliance programs.
Strong knowledge of risk assessment, CAPA, and compliance documentation management.
Proficiency in preparing audit reports and compliance documentation.
Excellent organizational and project management skills, with the ability to handle multiple tasks simultaneously.

Behavioral Skills Required:

Strong attention to detail and a high level of integrity.
Excellent interpersonal and communication skills, both written and verbal.
Proactive approach with strong problem-solving capabilities.
Ability to work independently and in cross-functional teams.
Ability to maintain confidentiality and handle sensitive information with discretion.
Leadership skills to effectively manage audits and compliance initiatives across the organization.

Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.

Biotech Healthcare

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