Company Overview:

At Meitheal Pharmaceuticals, we are dedicated to delivering high-quality generic and biosimilar pharmaceutical products to improve patient outcomes worldwide. With a commitment to excellence and innovation, we strive to set new standards in the pharmaceutical industry. As we expand our portfolio and global presence, we are seeking a dynamic and experienced Vice President of Quality Assurance to join our team and lead our quality initiatives.

Position Overview:

As the Vice President of Quality Assurance, you will play a pivotal role in shaping and implementing our quality strategy across all aspects of our operations. Reporting directly to the executive leadership team, you will be responsible for ensuring compliance with regulatory requirements, fostering a culture of continuous improvement, and maintaining the highest standards of quality throughout our organization.

What you will do:

• Develop and communicate a comprehensive vision for quality within the company, encompassing both generic and biosimilar pharmaceuticals.
• Lead the Quality Assurance department, overseeing all quality functions including product development, distribution, supplier management, and contract manufacturing.
• Establish and maintain an effective Quality Management System (QMS), ensuring adherence to FDA regulatory requirements, ICH guidelines, and industry standards.
• Drive the development and implementation of strategies to enhance quality performance and mitigate risks.
• Manage regulatory agency interactions, including preparation for and response to FDA inspections.
• Lead recall procedures and oversee the execution and communication of field alerts and recalls.
• Provide strategic direction for timely and complete responses to quality-related regulatory queries.
• Collaborate cross-functionally to ensure alignment with company objectives and goals.
• Oversee staff training, development, performance management, and recruitment within the Quality Assurance department.
• Monitor key quality metrics, analyze insights, and report findings to senior management during management reviews.
• Manage the quality department budget to support company objectives effectively.

What you need to be successful:

• Bachelor's degree in a scientific discipline required; advanced degree preferred.
• Minimum of 15 years of experience in the pharmaceutical/biotechnology sector, with at least 10 years in a leadership role within Quality Assurance.
• Expert knowledge of FDA regulatory requirements, ICH guidelines, and industry standards.
• Proven track record in successfully managing inspection readiness programs and regulatory inspections.
• Strong leadership skills with the ability to influence and effect change within the organization.
• Excellent communication and collaboration skills, with the ability to build strong working relationships cross-functionally.
• Demonstrated ability to drive results and improve business performance.
• Willingness to travel up to 25%, domestically and internationally.

What You'll Love About our Company:

• Watching your hard work have a direct impact on the success of the company.
• Hybrid Work Environment.
• Competitive Pay.
• Medical, dental and vision insurance.
• 401K Company Match.
• PTO and paid holidays.
• Company paid wellness resources and fitness programs.
• Relaxed, casual dress code.

Equal Opportunity Employer:

Meitheal Pharmaceuticals is an equal opportunity employer committed to diversity and inclusion in the workplace. We welcome applicants from all backgrounds and strive to create a supportive and inclusive environment for all employees.

Women/Veterans/Disabled.

If you are passionate about quality and eager to make a difference in the pharmaceutical industry, we encourage you to apply for the Vice President of Quality Assurance position at Meitheal Pharmaceuticals. Join us in our mission to improve patient lives through excellence in quality and innovation. Apply now!