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 EPD

• Develop 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 requirements

• Represent the Commercial Affiliate on Cross-Region teams, projects or issues as required

• Interpret and evaluate local market regulatory requirements and standards

• Provide integrated QA support in QA related issues for EPD Supply Chain

• Provide support to local outsourcing activities and product launches through management of the First Lot Quality Review program

• Assure 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 targets

• Manage 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 Implementation

• Responsible for supplier management of local suppliers including qualification and performance monitoring

• Ensure compliance of imported and TPM product labeling as per regulatory approval

• Managing 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 investigation

• Close complaint record and communicate to complainant

• Handles non-medical complaints – receipt, investigation, evaluation, response, closure and maintenance

• Work with Global Product Protection and BPOM for any Counterfeit, Diversions, Tampering, Theft issue

• Other 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/Regulatory

• 2-3 years’ experience with management of complex projects or programs

Core Skill Requirement

• Adaptability, Initiative, Integrity

• Planning and Organizing

• Ability to prioritize

• Ability to use Quality Tools such as benchmarking, gap analysis, pareto analysis, fish- bone diagrams, and process mapping for fact base decisions making

• Project management and troubleshooting skills

• Fluent in English. Ability to communicate both written and orally, to all levels of management and across different cultural backgrounds

• Knowledge of local regulations for quality systems and compliance

• Ability to identify problems, and initiate corrective actions and preventative actions

• Sound decision-making skills contributing to high levels of competence, confidence and credibility are required

• Well-developed interpersonal, communication and negotiation skills

• Continuous improvement methods and application (for example: Lean, Six Sigma, Class A, etc.)

• Change management

• Experience in or working with regulatory organizations

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com