QA Director
Brief Job Summary:
Oversee & coordinate assigned QA program in support of customer accounts, audit and inspection program, or QA quality management system at a regional and/or global level. Provide insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation, quality, process, productivity/efficiency improvement initiatives. Manage the quality assurance oversight of projects, assignments, training and staff.
Key Responsibilities and Roles:
Build up the quality system according to FDA requirements.
Serve as the QA Contact for assigned internal/external customers.
Assist in the enhancement of Quality Assurance and control policy, and risk identification and mitigation by providing consultation & recommendations to regional or Global QA Management.
Provide Quality Assurance support, guidance and management of critical Quality Issues, as assigned.
Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies.
Serve as an author for QA Standard Operating Procedures (SOPs), and act as regional QA representative to the global QA SOP taskforce.
Host customer audits and participate in review of corrective action plans, as assigned.
Oversee proper coordination of customer-initiated audits and mock regulatory inspections, manage regulatory facility inspections, as assigned.
Plan, schedule, conduct, report and close audit activities, as assigned.
Provide Quality Assurance support, guidance and management of critical Quality Issues, as assigned.
May accompany junior auditors for training / assessment purpose, as assigned.
Oversee documentation, reporting, and closure of compliance issues.
Support Quality Management in proposal reviews and reporting QA metrics
Conduct trend analysis of audit results, provide to internal/external stakeholders as agreed, as assigned.
Participate in or lead (cross functional) teams for special projects as assigned.
Promote the concept of quality, the principles of quality management and devise and implement quality improvements.
Other tasks assigned by the supervisor.
Qualifications:
At least Bachelor's Degree
7 - 10 years experience Quality Assurance experience in pharmaceutical, technical, CDMO or related area.
Knowledge of word-processing, spreadsheet, and database applications.
Strong knowledge of pharmaceutical research and development processes and regulatory environments.
Considerable knowledge of quality assurance processes and procedures.
Strong interpersonal skills and the ability to positively influence and guide others.
Excellent problem solving, risk analysis and negotiation skills.
Effective organization, communication, and team orientation and leadership skills.
Possess applicable experience in conducting audits, writing audit reports and analyzing audits.
Demonstrated ability to lead and manage multiple responsibilities.
Identify functional constraints and identify solutions.
Ability to coordinate timelines with internal customers and external vendors.
Ability to manage multiple activities and timelines.
Ability to articulate and define departmental needs and processes.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.