The Healthcare Quality Assurance (QA) Associate Manager communicates the quality policy and objectives to help ensure the maintenance of the overall healthcare compliance for the operation/department. He/She reviews global standard operating procedures (SOPs), reviews and approves client and facility work instructions, trains QA personnel and internal clients on SOPs and regulatory topics, and oversees the maintenance of the quality management system. This position participates in internal, client, and agency audits, and follows up on audit outcomes. He/She maintains knowledge of healthcare quality and regulatory requirements and assesses and addresses risks associated with changes as well as transporting healthcare products. This position oversees multiple facilities and supervises specialists.
Responsibilities
Interfaces with Internal Groups, Clients, and Agencies
- Consults with internal groups (e.g., Operations, Building and System Engineering, Business Development, IT, etc.) and investigates and resolves healthcare issues to ensure compliance with rules and regulations.
- Assists with internal groups (e.g. Business Development, Solutions and Implementation, Operations, IT, etc.) to review new business opportunities to advise on certification and licensing requirements to be in compliance with ever changing local regulations and global SOP.
- Reviews policies, procedures, and regulations with clients to determine specialized requirements and ensure compliance.
- Interfaces with client QA departments and attends sales presentations and business reviews to support the coordination of client activities.
- Participates in regulatory agency interactions to interpret rules and regulations.
- Assists in agency follow-ups after inspections and discovery of internal issues to meet respective agency requirements.
- Follows up with clients after audits to identify issues and mutually acceptable solutions.
Maintains Quality Documents and Procedures
- Writes and revises global standard operating procedures (SOPs) and performs random process adherence audits to ensure adherence to global and client specific processes.
- Establish and maintain postponement activities (e.g. kitting, labelling, bundling, repackaging etc)
- Assists in coordinating document and data control (e.g., numbering, version control, controlled copies, etc.) to ensure documentation and data meet quality standards and are orderly maintained.
- Establishes and maintains quality policies and programs to ensure proper document and data control methods are utilized.
- Assists in interfacing with Corporate Compliance and evaluates procedures across locations to ensure no overlaps and gaps in procedures and guidelines and consistency in content and implementation exist.
- Suggests quality improvements to SOPs, operational/department procedures, and client work instructions to ensure quality standards are maintained.
- Reviews and approves client specific work instructions to ensure consistency and compliance with applicable regulations and UPS quality standards.
- Provides recommendations for changes to work instructions as necessary to accurately reflect regulations and UPS quality standards.
Supervises And Develops Others
- Determines employees’ training needs to produce continuous development plans.
- Provides on-going feedback and support to improve performance.
- Conducts performance evaluations in a consistent, fair, and objective manner to encourage continuous performance improvement.
- Holds others accountable to established performance levels to achieve individual and group goals.
- Resolves individual and group performance issues in accordance with UPS’s policies and procedures in a timely manner to motivate and foster teamwork.
Manages and Executes Quality System Training Program
- Identifies any necessary and applicable Quality System requirements to ensure appropriate training content.
- Performs necessary Good Manufacturing Practices (GMP)/Good Distribution Practices (GDP) and SOP training to ensure appropriate level of compliance is maintained in the operations/department.
- Identifies and approves all qualified trainers to ensure training quality.
- Assists in the development and maintenance of all necessary training material to ensure quality and accuracy of content.
- Oversees the tracking and reporting of required employee training for the facility/department to ensure compliance.
Conducts and Oversees Internal and External Audit Programs
- Participates in information gathering and scheduling and prepares and distributes reports to prepare for internal and client audits.
- Performs internal audits, interacts with internal auditees, and records information and observations to track and trend audit findings, take corrective and preventative action, and maintain proof of audits and documentation.
- Hosts and responds to Corporate Compliance and agency audits to identify and conduct follow-up activities.
Requirements:
- Possess a Degree in Science or Life Sciences related
- Need to be a license Pharmacist and willing to be a license holder for SG Healthcare facilities
- Brings along at least 5 years of work experience in pharmaceutical/medical device logistics related field
- Good interpersonal skills with the attributes of a team player and a keen eye for details
- Ability to collaborate and work effectively with a variety of stakeholders
- Able to travel occasionally to APAC countries
- This position is based in the West (1 Gul Circle).
