ROLES & RESPONSIBILITIES

1, Summary:

Quality System implementation at the local EPD Commercial site and assures that quality related matters associated with products commercially distributed including those from Local TPM conform to current Good Manufacturing Practices (cGMP), Abbott Quality standards, and other applicable regulatory standards.

2, Core job responsibilities:

Quality System

Implement and manage quality systems and training programs as necessary to support CAPA, validation, complaint registration, physician sample handling, inspection reporting and tracking, policy implementation, supplier management, document and change control management, distribution and material control at the local commercial EPDDevelop and maintain Commercial Quality Management System Manual while minimizing cost increases and potential disruptions to business.  Ensure the implementation and maintenance of activities related to compliance to policies, processes, procedures and plans that define these elements necessary to meet the Quality objectives, along with Regulatory and business requirementsRepresent the Commercial Affiliate on Cross-Region teams, projects or issues as requiredInterpret and evaluate local market regulatory requirements and standardsProvide integrated QA support in QA related issues for EPD Supply ChainProvide support to local outsourcing activities and product launches through management of the First Lot Quality Review programAssure that quality related issues associated with products distributed / products distributed conform to current Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Company Corporate and Divisional Quality standards, and other applicable regulatory standards in order to assure readily available supply of compliant, authentic, safe and efficacious products at market competitive cost

Quality Metrics

Ensures implementation of quality metrics at all relevant departments, including adherence to set targetsManage Management Review process for Commercial Affiliate and elevate any significant events or identified risks to management.

Quality Audit Program /Supplier Management

Manage Internal Audit/self-inspection at Commercial Affiliate to ensure effectiveness of Quality System ImplementationResponsible for supplier management of local suppliers including qualification and performance monitoringEnsure compliance of imported and TPM product labeling as per regulatory approvalManaging potential on-market issues for local and imported product including TPM products, to document decisions and all Agency communications/actions

Quality Complaints and Pharmacovigilance

Inform ASR or PV of all complaints related to adverse events (AE’s)Register all non-medical/medical QA related complaints via SolTraq and forward complaint to manufacturing site for investigationClose complaint record and communicate to complainantHandles non-medical complaints – receipt, investigation, evaluation, response, closure and maintenanceWork with Global Product Protection and BPOM for any Counterfeit, Diversions, Tampering, Theft issueOther work/function that may be assigned.

MINIMUM BACKGROUND/ EXPERIENCE REQUIRED

Work Experience:

At least 5 years’ experience in Pharmaceutical or medical device (or related industry) QA/Regulatory2-3 years’ experience with management of complex projects or programs

Core Skill Requirement

Adaptability, Initiative, IntegrityPlanning and OrganizingAbility to prioritizeAbility to use Quality Tools such as benchmarking, gap analysis, pareto analysis, fish- bone diagrams, and process mapping for fact base decisions makingProject management and troubleshooting skillsFluent in English. Ability to communicate both written and orally, to all levels of management and across different cultural backgroundsKnowledge of local regulations for quality systems and complianceAbility to identify problems, and initiate corrective actions and preventative actionsSound decision-making skills contributing to high levels of competence, confidence and credibility are requiredWell-developed interpersonal, communication and negotiation skillsContinuous improvement methods and application (for example: Lean, Six Sigma, Class A, etc.)Change managementExperience in or working with regulatory organizations