The Director, Quality Management provides strategic leadership, direction, and oversight for Quality Management activities (Risk Management, Compliance Management, Supplier Evaluation/Assessment and Auditing, and Training) for Product Supply Biotech globally. The Director will establish quality practices and systems including oversight of the CAPA system and customer complaints. The role will also be responsible for generating, establishing and maintaining Product Supply Biotech Quality Policy and Standards that address regulatory requirements and our companies Compliance Policies and Directives.

Tasks:
-Provides effective leadership including: developing and implementing objectives and business strategies; selecting key personnel and motivating members of the functional area; challenging employees to develop as leaders while serving as a role model and mentor; assisting with Performance Calibration/Talent Pool Management/Succession Planning; individual goal setting/performance reviews; training and development; supporting workforce diversity, quality and safety and supporting supervisors/managers in the management of their employees/department which support achievement of individual/department/business objectives.

-Oversees Quality System development, implementation and continuously monitors and updates as required by new developments in global regulations; regulatory compliance, and quality related issue management systems (risk management, supplier management, CAPA, and customer complaint procedures); maintains current knowledge and understanding of global regulations and creates awareness of the regulations within the Product Supply Biotech (PS Biotech) organization.

-Ensures PS Biotech Directives conform to the requirements of our company's policies and applicable regulatory requirements globally; final authority for engineering design, validation and procedural requirements for all PS Biotech sites.

-Defines and executes the strategic audit program across Suppliers; establishes supplier relationship standards and processes; participates in Corporate Planning for audits and supports global TAC Auditing Program with SMEs and auditors; participates in Corporate Auditing and Supplier Evaluation Councils; liaison to our company's central GMP audit function.

-Oversees global PS Biotech Compliance Training Program and Training Management system, establishes training curricula and documentation standards and acquires third party training modules or develops custom compliance training as appropriate.

-Oversees from a global perspective, local site responses to inspection findings and reporting of status to Regulatory Affairs.

-Ensures the evaluation and analysis of all Biotech Product Technical Complaints on a global level to detect and correct trends by implementing appropriate CAPAs; reviews complaints globally with Global Pharnacovigilance for safety relevant signals.

-Chairs Global Quality Management Review meetings and global review across all PS Biotech sites to initiate, monitor, and coach Corrective and Preventative Action teams and maintain the Compliance Priority Portfolio. In the absence of the VP Global Quality Biotech, chairs Product Quality and Safety Committees.

The Director, Quality Management operates in the highly and tightly regulated industry of Biological Products. Issues relating to regulatory compliance are frequently very complex and challenging due to the biological variability inherent in working with biotechnology products. Substantial compliance with cGMP regulations and standards established by federal law is required to lawfully ship products in domestic and international commerce. Failure to achieve compliance may result in legal action against the company and individuals with senior management responsibility and inability to release and ship products.

The continuous monitoring of Product Technical Complaints is an integral part of our company’s strategy to assure patient safety and provide patients with high quality products and drive improvements in its product portfolio. The Supplier Evaluation/Assessment and Auditing Program assures that purchased goods and services comply with international GMP standards and our company's specifications seeking to build Manufacturer/Supplier relationships for the mutual benefit of companies and allows for the integration of suppliers into our company’s business processes.


Requirements:
-Master's Degree in a science or technical field.
-10 years of experience in pharmaceuticals or a related industry with 8 years in management positions and 8 years quality assurance, quality systems, quality management or regulatory management experience or an equivalent combination of education and experience.
-In depth knowledge of quality philosophies, systems, methods, tools and standards.
-Understanding and application of risk-based decision making in manufacturing of aseptic products.
-Broad cGMP experience and knowledge, QA/QC and regulatory compliance (US and other international agencies).
-Strong leadership and interpersonal skills (6-8 direct reports).
-Skilled in achieving results and managing others to achieve corporate, site, and departmental objectives.
-Excellent communication skills, good presentation and influencing skills.
-Ability to interact and gain the support of senior management.
-Ability to effectively manage multiple, complex priorities.
-Ability to work cooperatively in teams and peer relationships.

Candidates Must Have:
Master's or Ph.D
Compliance experience
Large Pharma/biotech corporation experience
Audit Experience
Quality Experience