VP, Regulatory Affairs and Quality Management
Remote
Full Time
Senior Executive
As The Vice President of Regulatory Affairs and Quality you will lead and oversee the regulatory and quality functions within Catalyst. This executive role is critical in ensuring compliance with international regulatory standards, driving quality initiatives, and supporting the organization’s strategic goals. You will work closely with senior leadership, clients, and regulatory bodies to navigate complex regulatory landscapes and maintain the highest standards of quality across all operations.
You will also implement the associated processes and oversight for the Quality Management department and corporate Quality Management Systems (QMS) at Catalyst.
You will be responsible for procedures, processes, policies/SOPs, activities, initiatives, and oversight that are highly effective to meet the needs of the company and conform to applicable regulatory requirements. You will be responsible for the implementation and maintenance of a Quality Management Framework for the organization and oversee adherence with ICH /GCP and data protection principles across Catalyst. In this role you will lead and drive through a close collaboration with other peers and leaders to build a quality and regulatory compliant culture.
Position Accountabilities/Responsibilities:
Regulatory Strategy and Compliance:
Position Qualifications and Requirements:
Education:
Required Certifications: Certification or membership to a Quality or Regulatory Association is preferred but not required.
Required Skills:
You will also implement the associated processes and oversight for the Quality Management department and corporate Quality Management Systems (QMS) at Catalyst.
You will be responsible for procedures, processes, policies/SOPs, activities, initiatives, and oversight that are highly effective to meet the needs of the company and conform to applicable regulatory requirements. You will be responsible for the implementation and maintenance of a Quality Management Framework for the organization and oversee adherence with ICH /GCP and data protection principles across Catalyst. In this role you will lead and drive through a close collaboration with other peers and leaders to build a quality and regulatory compliant culture.
Position Accountabilities/Responsibilities:
Regulatory Strategy and Compliance:
- Develop and implement regulatory strategies to ensure compliance with global regulatory requirements for customers development plans and operational programs.
- Serve as the primary liaison with regulatory agencies, including the FDA, EMA, and other international bodies.
- Develop the strategy for the preparation, submission, and maintenance of regulatory filings and documentation, to meet customer commitments.
- Monitor changes in regulatory environments, assess their impact on the organization and educate our workforce.
- Represent the organization at industry conferences, regulatory meetings, and client presentations.
- Establish, develop and implement the strategic quality vision, including the Quality Management Systems, at Catalyst corporately as well as the Quality Management function. Provide Quality input to Catalyst strategic goals.
- Oversee the design, implement and maintain (GxP) programs and framework, which includes the QMS maintenance, SOPs, training programs, issue management and performing internal and external audits.
- Drive continuous improvement initiatives and projects to improve processes and the QMS.
- Lead coordination with regulatory agencies and other external auditors to building trust and confidence in the company’s quality systems and processes.
- Identify areas of failure or gaps within processes, ensuring that appropriate levels of control are in place to meet defined regulatory requirements, customer expectations and business objectives.
- Lead quality input on contracts or RFIs/RFPs and serve as the primary Quality contact or assign a designee for the negotiation of quality agreements.
- Oversee the development, maintenance, and continuous improvement of Catalyst’s processes and procedures, along with the implementation of Quality Event and CAPA processes and systems.
- Develop, execute, and maintain risk-based audit strategies to ensure that systems and clinical trial activities performed by Catalyst are conducted in compliance with applicable regulations, ICH/GCP guidelines, Catalyst procedures, and clinical trial protocols.
- Develop, execute, and maintain risk-based audit strategies to ensure that activities performed by Catalyst are conducted in compliance with applicable regulations, ICH/GCP guidelines, Catalyst procedures, and clinical trial protocols.
- Provide input in the development, [management] and adhere [monitor adherence] to the overall Quality Management budget.
- Develop, analyze, and report business metrics and highlights.
- Lead the management of the Quality Event and CAPA process and activities.
- Ensure the development of quality in support of overall business goals.
- Participate in departmental, inter-departmental, and management planning and work cross-functionally to improve processes within the organization.
- Ensure support is provided for client projects in areas of Quality as defined within an agreed proposal including areas such as clinical trials and consulting.
- Coordinate and assign work across the Quality Management team, including local and regionally aligned staff.
- Represent Catalyst Quality and the Quality Management function to sponsors, the clinical research industry, and internally at Catalyst.
- Foster and promote a GCP-compliant environment with internal and external stakeholders.
- Provide expertise and guidance to in interpreting and implementing regulations and clinical research guidelines to assure compliance.
- Develop and mentor a talented global Quality Management team.
- Lead, manage and/or oversee sponsor audits of Catalyst including the preparation of the project teams, hosting/facilitating the sponsor audits, reporting the outcomes of the audit to the Catalyst senior management, responding to sponsor audit findings, and trending audit observations as part the Catalyst process improvement programs.
- Lead regulatory inspections of Catalyst including the institution of comprehensive GCP inspection readiness plans which require overall management of a large cross-functional team.
- Identify, communicate, and escalate GCP corporate risk, scientific misconduct, and serious noncompliance situations and follow to resolution.
- Establish effective communication of audit and inspection outcomes, developing metrics, measuring trends, and driving improvements.
- Ensure development of the proper communication and training that meets regulatory, GCP and ICH requirements be in place across the organization.
- Ensure the organization’s need to be up to date on knowledge of relevant data privacy laws and regulations as well as the appropriate policies and procedures are in place to adhere to requirements and commitments.
- Represent the Quality Management group within the Executive Leadership Team (ELT); attend performance review meetings, build and present tracking sheets and other initiative overview reports, lead relevant projects as Business Sponsor or Process Owner.
Position Qualifications and Requirements:
Education:
- At a minimum Bachelor’s Degree in Science or a related field. Advanced degree desirable but not required.
- Minimum of 18 years’ experience in the pharmaceutical or biotechnology industry in a quality or related field.
- Minimum of 12 years of Regulatory Affairs and GCP Quality experience or equivalent.
- Minimum of 8 years of experience of increasing management and leadership responsibility within a global pharma or CRO organization, embracing diverse cultures and Staff.
- Strong GxP knowledge and maintain a strong understanding of relevant regulatory requirements.
- Hands-on experience with implementing and managing Quality systems and processes infrastructure.
- Proven record of developing and maintaining successful working relationships with Sponsors and regulatory agencies.
Required Certifications: Certification or membership to a Quality or Regulatory Association is preferred but not required.
Required Skills:
- Proficient with Microsoft Office Suite.
- Excellent written and oral communication skills.
- Excellent presentation skills.
- Strong organizational, problem-solving, and analytical skills.
- Ability to manage priorities and workflow.
- Versatility, flexibility, and a willingness to work within constantly changing priorities.
- Proven ability to handle multiple projects and meet deadlines.
- Strong interpersonal skills.
- Ability to deal effectively with a diversity of individuals at all organizational levels.
- Commitment to excellence and high standards.
- Creative, flexible, and innovative team player.
- Ability to work independently and as a member of various teams and committees.
- Good judgement with the ability to make timely and sound decisions.
- In-depth knowledge of global regulatory requirements and quality standards.
Working Conditions: Mostly sedentary work that primarily involves sitting/standing, occasionally moving objects up to 50 pounds.
*Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa.*
*Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa.*
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