Vice President, Regulatory & Quality
Our client is a biopharmaceutical company specializing in immunomodulatory biologics. They have asked us to assist them in a search for a Vice President, Regulatory & Quality.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Holds responsibility for the regulatory and quality strategies as they relate to the development and commercialization of the company’s products.
- Establishes and maintains the company’s quality systems.
- Formulates company strategies and goals in collaboration with other leaders as a member of the executive team.
- Develops staff for the company’s regulatory and quality teams.
- Provides direction on regulatory and quality strategy to staff and project teams, both internally and externally.
- Serves as the primary contact to health authorities for meetings, applications, and inquiries.
- Acts as a strategic lead during the conduct of regulatory inspections.
- Represents the company during due diligence activities and on oversight committees with corporate partners.
- Directs the preparation of regulatory submissions in accordance with development plans and regulatory requirements.
- Holds responsibility for the implementation and oversight of documentation systems for managing data required for regulatory compliance.
- Develops and maintains internal and external audit programs to satisfy contractual and regulatory requirements for GXP.
- Evaluates and selects contractors and consultants as necessary to support the preparation of regulatory submissions and routine inspection of company quality systems.
- Identifies deficiencies or potential regulatory deficiencies related to product, process, or
quality systems and coordinates their resolution.
- Maintains awareness of new and proposed regulatory requirements, assesses impact to the organization, and informs the leadership team accordingly.
- Establishes and maintains practices that are compliant with current regulatory guidance on GLP, GCP, and GMP expectations.
- An advanced degree such as a Master of Science or PhD is required.
- Requires 10+ years of pharmaceutical industry experience in Regulatory Affairs
and Quality Assurance.
- Must have working knowledge of drug submissions and ICH standards including GLP, GMP, and GCP.
- Requires excellent people management skills with the ability to lead direct reports.
- Must have extensive experience developing, maintaining, and improving quality systems and processes.
- Must be adept at formulating and driving strategy.
- Requires an advanced understanding of regulatory and industry quality standards and associated processes.
- Requires a proven track record of working in a cross-functional environment.
- Must have experience in hosting and leading FDA and other regulatory authority audits, as well as prior oversight of regulatory authority inspection preparedness.
- Experience representing the regulatory function to health authorities and external thought leaders is required.
- Must have strong negotiating, problem solving, and communication skills both written and verbal.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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