Job Detail

Job Description

Responsibilities:

• Lead projects that impact the Quality Management System. Report on progress against schedules, milestones and project goals, evaluate project resource needs and availability, identify and report gaps or project constraints, and develop solutions for successful implementation.

• Enforce compliance with QA processes, Equipment Qualification, and Computer System Validation principles. Support all regulatory and customer quality audits.

• Manage direct reports – Lead and coach team driving a high performance organizational culture.

• Gather, organize & analyze data to develop solutions & alternative methods of proceeding; execute continuous improvement projects to optimize operations to deliver process improvements

• Assist CAPA teams, and other project teams, in the development of action plans and implementation schedules, and the verification of completed actions.

• Identify compliance issues that require follow-up or investigation.

• Conduct or direct the internal investigation of compliance issues.

• Conduct or direct the internal investigation of customer complaints.

• Track compliance issues within all departments and ensure completion within defined timelines.

• Assess product, compliance, or operational risks and develop risk management strategies.

• Disseminate written policies and procedures related to compliance activities.

• File appropriate compliance reports with regulatory agencies.

• Evaluate testing procedures to meet the specifications of environmental monitoring programs.

• Verify that software technology is in place to adequately provide oversight and monitoring in all required areas.

• Maintain documentation of compliance activities, such as investigation outcomes.

• Consult with corporate attorneys as necessary to address difficult legal compliance issues.

• Discuss emerging compliance issues with management or employees.

• Advise internal management or business partners on the implementation or operation of compliance programs.

• Provide assistance to internal or external auditors in compliance reviews.

• Prepare management reports regarding compliance operations and progress.

• Monitor compliance systems to ensure their effectiveness. Oversee internal reporting systems such as corporate compliance hotlines and inform employees about these systems.

• Develop or implement environmental compliance plans for programs, such as air, surface and personnel sampling.

Requirements:

• HND / Degree degree with 10 years of pharmaceutical industry experience in quality assurance/quality control or an equivalent combination of education and experience in a scientific or health-rated field

• Minimum 5 years directly related experience supporting compliance in a quality/compliance function /applicable compliance field.

• Knowledge of QMS and CAPA related tools or systems is required.

• Environmental monitoring or audit experience is an asset