Quality Assurance and Pharmacovigilance Manager
JOB DESCRIPTION:
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.
Primary Function:
Covers the responsibilities of Quality Assurance, Pharmacovigilance and new product introduction in Singapore.
Major Responsibilities:
Quality Assurance (Singapore)
a. Quality System
Implement and manage local 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.
Develop and maintain 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 affiliate in projects or issues as required
Interpret, evaluate and update management on local regulatory regulations, 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.
Responsible for management of local over-labeling/ redressing activities and ensure the activities comply with GMP, Company Corporate and Divisional Quality standards and local regulatory standards.
Provide instructor-led training for quality activities and systems such as DARIUS, ISOtrain and SolTRAQs.
Responsibilities for document creation and maintenance in DARIUS
Perform ISOtrain training coordinator role to create courses, modules, generate monthly reports and carryout reconciliation of overdue trainings.
b. Quality Metrics
Ensures implementation of quality metrics at Affiliate level, including adherence to set targets and goals.
Maintain Management Review process for Affiliate and elevate any significant events or identified risks to management.
Act as the key Affiliate contact for both internal audits and Regulatory Authority inspections
c. Quality Complaints
- 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 Security and HSA for any Counterfeit, Diversions, Tampering, Theft Issue
d. 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 products including TPM products, to document decisions and all Agency communications/actions
Pharmacovigilance Affiliate Safety Representative
Maintenance of the Affiliate PV System Country Chapter and additional local PV procedures, forms, and templates
PV business continuity planning and notification of any business interruptions that pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance
Receipt, recording, and reconciliation of safety information
Safety surveillance including literature and health authority website screening and preparation of local periodic safety reports and Risk Management Plans
Regulatory submission of safety information
Basic PV training of local EPD staff
PV record retention and archiving
Implementation of out-of-office coverage for receiving and recording safety-relevant information
Maintenance of local PV product list
Ensure PV matters in local interventional studies and local non-interventional organized data collection schemes
Negotiation and implementation of local commercial pharmacovigilance agreements and local pharmacovigilance service agreements
Due Diligence for product acquisition or in-licensing negotiated by an Affiliate organization
Provision of local PV Compliance metrics and management of non-compliances
Coordination/management of PV audits and inspections at the Affiliate level
Ensure vigilance compliant to local legislation for Abbott EPD products beyond medicinal products such as medical devices and food supplements
Support in preparation of Health Hazard Assessment/Medical Expert Statements
New Product Introduction (Affiliate)
a. Project Management (NPI)
Monitor and manage EPD Singapore NPI projects from End-to-End.
Collaborate with cross functional team including affiliate commercial, demand and supply, and finance teams on business case, forecast and P&L. Report and escalate business risk and opportunities to management, including delay in launch and mitigation plans.
Coordinate and facilitate the monthly affiliate NPI Reviews.
Support to ensure on-time product launch execution in market, including constant communication of product status to management.
Measure and report on time execution of launch activities. Identify performance gaps and ensure improvement actions, including Root Cause Analysis and Corrective Actions to minimize impact on business performance.
Lead the post launch assessment of products, project cancellation and discontinuation.
b. Subject Matter Expert on ATOM
Responsible for monitoring progress of milestones/activities in ATOM and deliverables in each ATOM stages.
Serves as the subject matter expert on ATOM and train new users on the ATOM system and process
c. Link between the Region and Affiliate
Ensure affiliate local process is aligned with the Region/Division NPI process and with the Business Excellence Standards.
Serves as the communication link between the affiliate and the Regional/Global NPI Function
Position Accountability/ Scope:
Quality Assurance
Responsible for ensuring that the affiliate implement and maintain cost effective quality systems solutions and remain in compliance with regulatory requirements.
Failure to meet this goal can result in the BU not fulfilling the commitments of the region/division or corporate compliance plans.
Financial penalties to the division, regulatory action and/or wasted resources are possible consequences.
Quality of products is a competitive advantage in the market place, and any lessening of our standards can have an adverse long-term impact on our business.
PV
The role takes responsibility for implementation and maintenance of a functional and compliant local PV system:
Implementation of local legislative and Abbott internal requirements in Singapore as the local PV interface to Health Authorities
PV point of contact for Affiliate non-PV functions and GPV headquarter
Works in collaboration with local non-PV stakeholders to maintain a timely and complete exchange of PV-relevant information
Supports the Manager PV Regional or GPV headquarter for specific global projects as assigned
Requirements:
Bachelor of Science degree or relevant disciplines
Minimum 4-5 years of quality assurance experience in pharmaceutical industry
PV experience is preferred
Ability to take the lead in driving projects and initiatives
Executive presence to participate in leadership meetings and discussions
Fluency in in written and spoken English
Well-developed interpersonal, negotiation and stakeholder management skills.
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.