Job Brief (Primary Responsibilities)
Responsible for assuring compliance with regulatory requirements (FDA, MDD, MDR) and ISO standards, with a focus on commercial support
Primarily responsible for assuring compliance with regulatory requirements (FDA, MDD, MDR) and ISO standards, with a focus on commercial support.
Will provide GLP, GMP, and ISO 13485 compliance support as necessary.
Primary Responsibilities :
Support Post Market Surveillance activities, including responding to product complaints and commercial product quality issues, preparing customer-facing communications, and performing data trending and reporting analyses as required.
Support supplier management program, including performing supplier quality audits and evaluations, interacting with suppliers on quality matters, implementing process improvements, and establishing / revising quality agreements.
Review and provide guidance for various non-conformance situations and investigations activities, evaluate root cause and corrective actions, and ensure documentation is complete, accurate, and closed in a timely manner.
Act as Quality lead on commercialization project teams.
Provide risk assessment expertise for internal projects and processes.
Audit study reports and raw data for compliance with protocols, SOPs and regulations.
Identify compliance weaknesses and ensure the implementation of workable solutions. Communicate compliance requirements at all levels.
Write / revise / review SOPs / INSs, prepare flow charts and other quality documentation, including investigation reports, audit reports, quality metric trend reports, etc.
Provide training and guidance in the areas of government regulations to effected employees.
May participate in and / or represent Quality Assurance on project teams within defined projects.
Perform other related duties as required.
Qualifications / Requirements / Skills :
Bachelor’s degree or equivalent in a scientific discipline with a minimum of 8 years’ experience in a pharmaceutical or medical device industry or Master’s Degree with a minimum of 5 years’ experience.
Minimum 3years’ experience in GLP or GMP operations.
Strong understanding of the FDA, GLP and GMP regulations and ISO 13485; GCP experience is a plus.
Ability to exercise independent judgment.
Strong data review and technical writing skills.
Direct experience with auditing techniques and evidence development.
High-level understanding of scientific approach and analytical thinking of others.
Strong communication skills (encompasses verbal, written, interpersonal, listening).
Ability to influence others.
High level of attention to detail and accuracy; very observant in order to audit properly.
Flexible; ability to adapt to changing priorities.
Excellent time management skills (schedules, timelines, task prioritization).