GMP Compliance Leader

This role provides advice and supports clinical staff and other relevant key stakeholders with regard to quality control, risk management, and corrective/preventive actions. Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program, monitor the implementation and delivery.

Job Title: GMP Compliance Leader
Job Type: Contract
Duration: 6 Months
100% Remote
Standard working hours 8am-4pm Mon-Fri with flexibility for occasional meetings outside standard working hours.


Job Title:
This role is an individual contributor assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the line manager (LM). The purpose of this role is to work together with global or regional Quality Management team(s), functional teams, and other stakeholders in a joint effort to clearly define the global Quality Plan, carry out, and adopt the plan according to the specific needs defined by the scope of assignment, assist staff in improving compliance with relevant International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Key Performance Indicators (KPIs), applicable regulatory requirements, and guidelines.
This role provides advice and supports clinical staff and other relevant key stakeholders with regard to quality control, risk management, and corrective/preventive actions.

Essential Functions:

• Perform and support batch disposition activities.
• Lead and/or support product quality complaint investigations.
• Manage and support investigations related to deviations and other quality events.
• Develop, review, and oversee CAPAs.
• Manage and support change control activities.
• Lead, coordinate, and participate in GMP audits.
• Provide direct strategic and operational Quality Assurance support to CClient and Supply Chain.
• Partner cross-functionally with internal stakeholders and external vendors to ensure ongoing GMP compliance.
• Support timely resolution of quality issues and escalation of significant compliance risks, as appropriate.
• Maintain appropriate quality documentation and ensure activities are completed in accordance with applicable GMP requirements and internal procedures.
• Adopt and implement the global Quality Management Plan within the scope of the assignment, this will include: Planning and executing the Quality Management activities. Risk identification and assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. Supporting the assigned business line management and staff to enhance effectiveness.;
• Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery.
• Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program, monitor the implementation and delivery.
• Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.
• Work in close cooperation with teams to manage non-compliance, quality issues, support in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs.);
• Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.;
• Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.
• Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
• May provide assistance during audits and regulatory inspections to the teams to the extent agreed with the business lines, as required by the applicable SOPs.
• Act as the primary contact for Quality Assurance on quality matters on the level of the assignment, attend meetings/teleconferences.
• Prepare periodic reports to business lines on quality related matters, risk assessments and specific quality improvement initiatives.
• Upon agreement with the line manager: Perform any other reasonable tasks as required by the role.;

Qualifications:

• Bachelor's Degree or equivalent qualification required
• Equivalent combination of education, training, and experience.
• Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management processes.
• Knowledge of National and International Regulations and Drug Development processes.
• Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations.
• Knowledge of corporate standards and SOPs.
• Good organizational, interpersonal and communication skills.
• Good judgement and decision-making skills.
• Strong influencing and negotiation skills.
• Strong computer skills including Microsoft Office applications.
• Excellent problem solving skills.
• Ability to lead and motivate a clinical team.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers.
• Fluent in English.