Associate Director, Quality Assurance Pharmacovigilance
Plano, TX, USA | Reata Pharmaceuticals, Inc.
Industry:Pharmaceutical / Biotech
Job Description:81 people have viewed this job
Supports pharmacovigilance in providing leadership and direction in achieving and maintaining global quality and mitigating compliance risk, regarding the pharmacovigilance aspect of the company Quality Management System.
Supports quality management in providing leadership and direction for Quality Assurance goals and operations. Contributes towards ongoing design, implementation, and maintenance of the company Quality Management System in compliance with regulations and standards, from product development through commercialization.
Responsibilities will include, but not necessarily be limited to, the following:
Plans, establishes, and manages standards and systems for the pharmacovigilance quality system.
Establishes key performance indicators for pharmacovigilance.
Establishes the audit plan for the pharmacovigilance group; coordinates and/or conducts audits of the pharmacovigilance processes.
Participates in and supports pharmacovigilance inspections.
Contributes in the monitoring and analysis of pharmacovigilance compliance data and sharing of emerging regulatory information.
Supports training with regards to pharmacovigilance regulations.
Oversees audit findings and ensures corrective actions are closed.
Primary quality contact for interactions with external Qualified Person responsible for pharmacovigilance.
Supports quality management in leading the development of a robust quality system, fostering best practices, and mentoring and consulting on Quality/Compliance within the pharmacovigilance organization.
Contributes towards the trending and reporting of quality related data to relevant staff members and senior management.
Develops strong collaborative working relationships with key stakeholders, inside and outside the Company.
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.
Contributes towards the identification and assessment of quality risks and ensures they are evaluated and managed appropriately to accomplish both business goals and regulatory and quality requirements.
Contributes to the development and administration of budgets, expenditures, and the allocation of resources for various quality projects.
Other duties performed as needed.
Demonstrates commitment and support for company goals, objectives, and procedures.
Represents Reata by developing collaborative relationships with site personnel, colleagues, and vendors.
Demonstrates professionalism and adherence to moral, ethical, and quality principles.
Participates in corporate and departmental meetings.
Complies with applicable regulations and corporate policies and procedures.
Minimum BA / BS or equivalent scientific degree is required; an advanced degree is preferred.
A minimum of 10 years of pharmaceutical industry experience in roles of increasing pharmacovigilance and quality assurance responsibility.
Comprehensive knowledge of global regulations and best practices for pharmaceuticals, along with an understanding of global quality standards and regulatory authority inspection trends in relation to pharmacovigilance product development, submission, and commercialization.
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.
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