Director of Quality System Compliance

Opportunity Highlights:

This role is responsible for providing expert guidance and direction on all compliance aspects regarding quality system operation in the GMP and ICH compliant Henlius Biopharmaceuticals for new and existing products.  This position will act as the Subject Matter Expert (SME) within the organization with the main objective of improving the overall compliance culture throughout the Henlius facilities and sites.  This position will be responsible for advising managers and other colleagues on compliance issues and will lead compliance projects when necessary.  Primary duties will include identifying the root cause of compliance issues through internal / external audits and regulatory inspections, deviations and OOS investigations, participation in batch review and change control dialogue.  Serving the quality system SME, this individual will be responsible for influencing management team on all compliance issues and for developing best practices and action plans according to the GMP regulatory requirements and company quality standards.  The incumbent will also be responsible for advising management on internal, external audits and regulatory inspections, with continued business growth.  He or she will also play an integral role in a cross functional team focused on new product development.

In summary, this is a rare and excellent opportunity to join Shanghai Henlius Biopharmaceuticals during a period of rapid development and growth.  This position is highly influential and critical to achieving compliance improvement and as a result contributing to the organization’s strategic goals for continued growth and commercial success.

Responsibilities: 

• Responsible for leading and managing Henlius Biopharma’s quality system improvement initiative across all departments and functions to ensure that quality initiatives and quality plans are executed and maintained in full compliance with CGMP requirements.  This includes addressing issues from quality management oversight and helping the site management team to execute effectively the quality enhancement activities.
• Ensure an effective review on suitability and effectiveness of quality system at defined intervals.
• Direct and support the resolution of quality problems in the facility activities so that they are consistent with the industry and company quality standards.
• Support and supervise quality governance through review of project documents, KPIs, risk assessments, and quality plans.
• Identify and support continuous improvement projects in collaboration with site management team with the objective of achieving quality, reliability and cost improvements.
• Attend preparation and execution of internal, external and regulatory audits on the site.
• Participate in or manage quality assessments related to the introduction of new products into the facility.
• Review and approve high-level quality documents
• Ensure that coordinated contact is maintained with other functions, including sharing of better practice and procedures.
• Ensure that company executive leadership team is well kept informed of all critical and major quality issues which may have an adverse effect on the product quality.
• Perform review of compliance performance at department and individual level and propose corrective actions.
• Provide coaching and direction for QA managers and team leaders, and provide training to relevant staff, as requested.
• Anticipate risks associated with product quality and regulatory compliance, through the prevention and reduction plans, including management of quality and product alerts.
• Provide quality support and expertise in the GMP projects such as nonconformance remediation plan, tech transfers, GMP facility projects, and the launch of new products.
• Provide support to sites as part of the regulatory inspections and external audits.
• Contribute significantly to the development of best practice within the scope of GMP compliance and regulatory requirements; facilitate interaction and exchange of best practices with other departments and functional areas.
• Develop GMP and QA knowledge and implementation to its highest standard, which is essential for the company to maintain its strong quality culture.
• Representing the quality team works closely with the heads of other line operations.
• Take strategic and leadership responsibilities in bridging between the site and the corporate quality management team. 

Qualifications: 

• Advanced degree (MS or PhD) within pharmacy, biology or engineering and with at least 10 years’ managerial experience in a production and/or quality function in the biotechnology/pharmaceutical industry.
• Expert in quality system implementation & improvement, which include but are not limited to Product Release & Production Batch Record, SOP, Training, External & Internal Audit, Regulatory Inspection, Change Control, Data Integrity, Customer Complaint Management, Qualification & Validation, Technology Transfer (Manufacturing Process & Analytical Method), Deviation and OOS Investigation, Quality Risk Management, External Supplier/Vendor Quality System, Quality Agreement, Quality Metrics, and CAPA Management for Non-conformance.
• Demonstrated leadership & experience in staff skill development, performance appraisal, and department budget management.
• Experience in transverse management without direct hierarchical authority or supervision. 

Key Competencies Required:

• Results orientated
• Demonstrated ability to achieve results and manage others to achieve corporate, site and functional objective
• Ability to integrate the constraints of each function and identify good solutions while within compliance of regulation
• Team performance complemented by development of skills and performance of individual team members
• Strong leadership
• Strategy development and execution
• Combined strategic and operational thinking
• Focus on goals
 with sound judgment
• Ability to manage multiple priorities and act with a sense of urgency
• Proactive and creative by designing new processes and implementation of those to promote process improvement continuously

Communication Skill

• Ability to work in highly diversified cultures
• Ability to work in a matrix, multicultural environment
• People management and development Skill
• Collaborates and communicates
• Leads others to work together
• Develops team capabilities and staff performance
• Rewards and recognizes desired performance
• Driven by building interpersonal and a proven team builder