Job Information
GE Healthcare Quality Leader, PDx Taiwan in Taipei, Taiwan
Job Description Summary
The Quality Leader is responsible for leading the Quality Assurance function in Taiwan to ensure compliance with current GMP, GDP, cGxP regulations (Taiwan FDA) with regards to the area of responsibility and specialization in support of continuous business and organizational growth. This role will also oversee various channel partner markets within the ASEAN sub-region.
This role will develop and maintain quality management systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
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Job Description
Roles and Responsibilities
Own the QA process under, e.g. Product Release, Complaint Handling, Investigations, CAPA, Warehouse Operations and/or 3PL management, Stability Data Review, Validation, Change Control Management, Training, Recall, Self-Inspection and Internal Audits, etc. within Taiwan and assigned ASEAN countries. Ensuring that a quality management system is implemented and maintained with focus on accuracy of records.
Be the GDP Responsible Person for PDx Taiwan and ensure any and all local regulatory requirements are adhered to.
Lead the preparation and execution of Quality Management Review for the country.
Manage quality evaluation of warehouse operations and manufacturing sites.
Provide support to routine activities, projects, continuous improvement activities, development and training relevant to area of expertise where and when required.
Ensure suppliers, customers, third parties and contract partners are approved and qualified via audit.
Ensure site audit readiness and internal audits and self-inspections are performed on time and at regular intervals and remediations are completed in a timely manner to address deficiencies.
Responsible for overseeing the execution of the final disposition of returned, rejected, recalled and falsified products and approving any returned to stock.
Analyze & communicate proposed, new or changing local regulatory requirements & devise strategies for their implementation, ensuring business goals are met.
Ensure on-time reporting of the metrics for quality management reviews.
Creates a Quality culture by driving compliance activities around a Pharmaceutical Diagnostics product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE HealthCare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.
Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy.
As an individual contributor with proven interpersonal skills, communication with direct colleagues and the business about coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations. Works collaboratively with local and global stakeholders on continuous improvement projects and solutions.
Impacts projects, processes and procedures in own field, focusing on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures.
Utilizes technical expertise and judgement to solve problems. Leverages technical skills, critical and analytical thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions/solutions.
Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.
Applies general knowledge of business developed through education or past experience. Understands how work of own team contributes to the area.
Resolves issues using established procedures. Consults People Leader or more senior team members for issues outside of defined parameters.
Collaborates with others to solve issues. For customer facing roles, develops strong customer relationships and serves as the interface between customer and GE. Exchanges technical information, asks questions and checks for understanding.
Handles simple data entry work requiring face value check and correction.
Required Qualifications
B.Sc. Degree in biology, chemistry, biochemistry, pharmacy, pharmaceutical sciences or technical field.
At least 7 years experiences in a regulated pharmaceutical, healthcare, medical technology or medical device industry
At least 5 years of GMP and/or GDP QA experience in a pharmaceutical, healthcare, medical technology or medical device company (combination of affiliate and manufacturing experience welcomed), of which at least 3 years in a supervisory or managerial role.
Demonstrated understanding, operational applicability and aptitude to understand Pharmaceutical and Medical Device QMS requirements and regulatory requirements including and not limited to Taiwan FDA GDP and GMP, ISO 13485, Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP).
Proficient with MS Office word processing, spreadsheet, presentation, and database applications.
Proficient with ERP systems (i.e. SAP) for product disposition management.
Proficient with eQMS (i.e. TrackWise) and eDMS (i.e. Veeva) systems.
Proficient with teleconferencing software platforms (MS Teams).
Critical and Analytical thinking: Ability to identify root cause of problem and creatively problem solve to gain resolution.
Ability to work independently in fast-paced environment with little supervision under normal and crisis situations.
Ability to adapt to constant change and influence positive change effectively.
Team-oriented, with experience in work with cross-functional teams across local and global scope and responsive to customer needs.
Quality-focused, attentive to detail and results-oriented.
Ability to communicate effectively in Mandarin and English (both written and oral).
Strong managerial, project management and time-management skills.
Experience in Lean thinking and execution.
This role requires advanced experience in the Quality & Life Sciences Quality. Knowledge level is comparable to a Bachelor's degree from an accredited university or college.
Desired Characteristics
Working experience in MNC pharmaceutical/healthcare/medical technology/medical device organizations
Experiences applying regulations (GMP, Good Distribution Practices)
Strong interpersonal skills for influencing, collaboration and networking.
Demonstrated collaboration and conflict resolution skills.
Demonstrated resilience in negotiation and teamworking skills.
Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, analyze, and execute programs. Established project management skills. Proven ability to communicate externally with customers and regulatory bodies and internal stakeholders and maintain positive relationships with those parties.
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.