Director, GMP/GDP Regulatory Surveillance (Hybrid)

Job Description

The Director CMC Compliance provides strategic leadership and quality oversight of the GMP/GDP Regulatory Intelligence and Surveillance space for small molecule, biologics and devices/combo devices globally. This role is recognized as a leader in the organization and an expert in the principles and application of quality and regulatory compliance. This position within the Quality Organization is vital to the advancement of excellence in navigating the changing regulatory landscape as well as understanding the requirements as Vertex moves into new global markets. The role is accountable for maintaining robustness of existing processes as well as developing innovative approaches to ensure continuous quality improvement. This role requires strong leadership skills, the ability to operate in a matrix organization as well as and the ability to be independent and autonomous. This role requires expert technical skills and demonstrated experience and capabilities in navigating regulatory requirements, assessing the Quality Management System for gaps and effectively implementing solutions and processes to close those gaps.

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• Drives continuous improvement in Vertex quality processes and governance to ensure Vertex remains adherent to regulatory expectations and supports QA operational quality oversight and a comprehensive Quality Management System (QMS)
• Accountable for developing and implementing strategies to translate Regulatory Intelligence gathering into action plans for all GMP/GDP regulations globally
• Collaborates with the CMC Compliance, QA Operations, International QA, Regulatory and Inspection Readiness teams to drive activities that ensure appropriate regulatory intelligence and compliance information is obtained, evaluated and actioned.
• Monitors and assesses all sources of global GMP/GDP intelligence information for relevance and impact to Vertex processes. This includes:
  • Draft guidance documents
  • Modified or newly implemented regulations
  • Intelligence for new markets/regions
  • Evaluation of QMS gaps for new modalities
• Accountable to analyze guidance and regulations from regulatory authorities and trade organizations and work cross-functionally to assess impact
• Identify and escalate potential risks and opportunities arising from regulatory landscape changes
• Project manage all gap assessments associated with Regulatory Intelligence/Surveillance to mitigate risks and prepare for launches in new markets as well as advance programs to comply to new standards and regulations
• Prepare comprehensive summaries, dashboards and robust project plans for communication with internal stakeholders and Sr. Leadership
• Establish and maintain robust systems to effectively monitor, analyze and implement global regulatory expectations
• Establish cross-functional working groups, including SMEs, to facilitate review and assessment of regulatory intelligence to identify action plans, gaps and risks
• Develop and implement strategies to ensure compliance with emerging regulations and regulations associated with new markets

Minimum qualifications:

• Demonstrated depth and breadth of global regulatory agency knowledge and GxP experience with current knowledge of industry trends and best practices for quality, efficiency, compliance and effectiveness
• Demonstrated working knowledge and application of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) including US and international/global regulatory requirements and associated guidances and standards (e.g. ISO, ICH, USP, etc.).
• Knowledge of Regulatory Intelligence tools
• Strong leadership skills with the ability to thrive in a fast-paced environment and act with urgency
• Strong problem solving and critical thinking skills, accompanied by analytical thinking/data analysis skills required to make sound decisions
• Demonstrated strategic planning and execution skills required
• Ability to monitor trends, detect shifts in requirements and implement strategies for compliance
• Current knowledge of industry trends and best practices for progressive quality management in a regulated environment
• Proven leadership capabilities within a multi-level organization to support development of individuals and teams
• Creative, innovative leadership experience with strong change management experience, adaptability and resourcefulness
• Excellent communication skills and a proven track record influencing/building/promoting a culture of Quality and Excellence
• Project Management / Continuous Improvement
  • Ability to lead and manage complex projects/teams with corporate objectives and project timelines
  • Proficiency utilizing project management processes / tools to lead meetings, project planning and facilitating completion key deliverables
• Cross-functional Collaboration
  • Ability to drive results, work collectively with stakeholders and maintain composure under pressure
• Communication/Coaching / Influencing
  • Ability to communicate effectively across all organizational levels
  • Presentation/Facilitation skills-ability to adjust presentation to audience and information real-time
  • Ability to effectively influence others within technical area of expertise
  • Recognized as a mentor with a strong ability to transfer technical knowledge and teach skills to junior staff
• Strong oral and written communication and interpersonal skills
• Excellent technical writing skills

EDUCATION REQUIREMENTS:

Master's degree and 8+ years of relevant work experience, or Bachelor's degree in a scientific or allied health field (or equivalent degree) and 12+ years of relevant work experience, or relevant comparable background.

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Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com