Associate Director, Quality assurance Compliance – Global Quality Risk Management
Foster City, CA, USA | Gilead Sciences
Industry:Pharmaceutical / Biotech
Job Description:53 people have viewed this job
The Associate Director, QA Compliance – Global Quality Risk Management will report to Director, Quality within the Supplier Management and Audits department.This role is primarily responsible for the development and implementation of a comprehensive, Global Quality Risks Management (QRM) program across Gilead.This role will have high visibility and requires strong leadership and collaboration with key stakeholders to meet Gilead’s business needs and regulatory expectations to ultimately ensure patient protection.
Develop and implement a sustainable Global QRM program, inclusive of risk management policies and procedures, tools, training, metrics, and a governance model to support the global program across the network.
Assess current procedures and risk management practices within various Quality Systems to ensure alignment and integration with the Global QRM program.
Develop and implement/deploy a systematic risk management lifecycle process to proactively identify, assess, control, communicate and review quality risks.
Facilitate risk assessment and development of risk mitigation strategies for quality risks.
Lead the development of training on QRM processes and risk management tools, and effectively roll-out to all levels of the organization.
Partner within Quality Assurance and other functions for communication and escalation of quality risks to Senior Leadership, while ensuring timely and adequate risk management.
Monitor and measure the effectiveness of the Global QRM program, providing periodic updates to Senior Leadership.
Review and revise procedures for consistency and compliance with regulatory requirements.
Represent the organization and act as a QRM subject matter expert during audits and inspections.
Lead global quality project teams.
Other responsibilities as required or assigned by Manager to meet business needs.
Supports management in maintaining the company’s Compliance program.
May manage the day-to-day activities of one or more individual contributors, including task assignment and prioritization, monitoring task performance, and conducting performance reviews.
Ensures awareness of compliance requirements and responsibilities within the function.
Establishes excellent working relationships with compliance/quality groups.
Responsible for maintaining current knowledge of applicable compliance requirements through attendance at industry and regulatory agency sponsored meetings and seminars.
Responsible for providing guidance on interpretation and application of existing and new requirements.Provide guidance to assigned departments and management when specific compliance issues arise.
Assists in evaluation and implementation of standard operating procedures and systems needed to comply with requirements.
Leads various types of audits or projects or supervises contractors. Audits may include internal systems audits, external vendor audits, or document reviews.
Assists in regulatory agency inspections. Assists in coordination of responses to any regulatory agency findings.
Knowledge, Experience & Skills:
Demonstrates excellent verbal, written, and interpersonal skills.
Demonstrates a thorough knowledge of compliance requirements and an understanding of current global and regional trends in compliance.
Is capable of taking a leadership role in updating and preparing the company for changes in regulations.
Is capable of leading a small team in development of systems and procedures and implementation.
Is well recognized as a knowledgeable resource for QA compliance advice in other departments.
10+ years of relevant experience in the pharmaceutical industry and a BS or BA.
8+ years of relevant experience and a MS.
Must have strong working knowledge of cGMP (FDA, EU and ICH Q9) requirements and the ability to assess compliance risks.
Extensive experience with developing and deploying a quality risk management program.
Working knowledge and hands-on experience with risk management tools (e.g. risk registers, FMEA, risk ranking and filtering, HACCP, etc.).
Excellent communication skills including ability to effectively speak with courage and candor across organizational levels and functions.
Charismatic leader with strong relationship building skills, and ability to influence and negotiate with cross-functional stakeholders.
Able to maintain a balance between being strategic/big-picture thinker and taking deeper tactical dives as needed.
Experience in developing and generating quality system metrics/trending.
Excellent project management skills.
Demonstrated ability to perform in a fast-paced environment