GMP Quality Assurance Compliance Specialist Job Durham area,North Carolina USA,Quality Assurance

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.
The purpose of this role is to work together with global or regional Quality Management teams, 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, and 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 CMC 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.
Planning and executing Quality Management activities, including risk identification and assessment through data review and quality control processes.
Providing support in risk mitigation, planning corrective/preventive actions, and offering guidance for improvement while supporting assigned business line management and staff to enhance effectiveness.
Cooperate closely with the relevant business lines and other stakeholders to support maintaining a focus on quality in project delivery.
Contribute to the development and implementation of a Delivery Unit or sponsor-specific Quality Management plan and Risk Management Program, and monitor 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 and quality issues, and support 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.
Work closely with Quality Assurance and assigned business staff in cases of suspected misconduct, as required by applicable SOPs.
Provide assistance during audits and regulatory inspections to teams to the extent agreed with business lines, as required by applicable SOPs.
Act as the primary contact for Quality Assurance on quality matters at the assignment level, attending relevant meetings and teleconferences.
Prepare periodic reports for business lines regarding quality-related matters, risk assessments, and specific quality improvement initiatives.
Perform any other reasonable tasks as required by the role upon agreement with the line manager.

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, and 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.
Strong organizational, interpersonal, and communication skills.
Sound judgment and decision-making skills.
Strong influencing and negotiation skills.
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 stakeholders.
Strong verbal and written communication skills.