Summary
Supports quality management in providing leadership and direction for all Quality goals and operations. Contributes towards ongoing strategy, design, implementation, and maintenance of the company Quality Management System in compliance with regulations and standards, from product development through commercialization globally. Partners with applicable internal functional areas in support of clinical IND programs as well as NDA filing and commercial product launch.
RESPONSIBILITIES
- Supports quality management in leading the development of a robust quality system, fostering best practices, and mentoring and consulting on Quality/Compliance issues across the organization.
- Plans, establishes, and manages quality activities supporting GMP, GLP, and GCP. Accountable and responsible for Document control- including but not limited to creating, revising, and providing workflows for review and approval of Quality documents such as SOPs, Protocols, Forms, Change controls, CAPAs, Training and others.
- Create, enhance, and provide various GMP trainings (new hire, refresher etc) to the entire organization. Support training materials for inspections and quality processes (e.g CAPA, Investigations etc). Contributes towards the trending and reporting of quality related data to relevant staff members and senior management
- Responsible for implementing and maintaining computerized systems that enable quality processes such as Veeva, Compliance, Wire etc
- Builds strong partnerships with cross functional team members and works with them to ensure personnel, process, documentation, and quality standards meet expectations for regulatory submissions, regulatory authority inspection readiness, and compliance with applicable guidelines
- Provides leadership in the support of changes in the organization, to continuously adapt to a dynamic business environment; applies learning to enhance organizational performance
- Fosters an environment of collaboration, trust, quality, innovation, and continuous improvement within the quality organization and between other functional departments
- Support creating QMS (processes, procedure, and roles) to enable the organizational model for product supply
- Help define various involved entities, QAAs and other documents that implement product flow and related SOPs. This includes global process for product management in accordance with the health authority expectations.
- Lead, participate and report on various audits (internal, vendor, HA inspections) as needed.
- Other duties performed as needed
CORPORATE COMMITMENTS
- Demonstrates commitment and support for company goals, objectives, and procedures
- Demonstrates professionalism and adherence to moral, ethical, and quality principles
- Participates in corporate and departmental meetings
- Complies with applicable regulations, corporate policies, and procedures
QUALIFICATIONS
- Minimum BA / BS or equivalent scientific degree is required; an advanced degree is strongly preferred
- A minimum of 12 years of Pharmaceutical industry experience in roles of increasing quality assurance responsibility. Global experience, with multiple health authorities required.
- Comprehensive knowledge of regulations and best practices for pharmaceuticals, along with an understanding of global quality standards and regulatory authority inspection trends in relation to product development, submission, and commercialization (GxPs)
- Demonstrated ability to provide leadership for key strategic issues and significant quality policies, practices, and processes
- Demonstrated ability to anticipate, proactively respond to trends and/or shifts in the external environment (e.g., regulatory, business partner relationships, industry standards)
- Excellent strategic skills with the ability to influence decisions at a senior level, both internally and externally
- Appreciation for all aspects of the pharmaceutical business, from research through sales and marketing, with the ability to operate cross-functionally and/or globally to achieve Company goals
- A "hands-on" self-starter with considerable managerial / leadership experience and a demonstrated ability to interact with various levels of management to accomplish goals and objectives
