Job Details

Our Company

For over 50 years, Rosemont Pharmaceuticals has been a trusted name in the development and manufacture of oral liquid medicines. With a portfolio of over 130 products — including 70 licensed medicines — we're proud to support healthcare professionals and patients, especially those with swallowing difficulties.

Our purpose is clear: to improve patient outcomes through innovation in liquid formulations. We're highly respected across the pharmaceutical industry and have played a key role in establishing best practices for dysphagia care.

Our mission is to create a globally connected, people-focused organisation where every individual is empowered to thrive and achieve their best. If you're passionate about making a meaningful impact to patients across the world and want to be part of a company with a strong heritage and ambitious vision, we'd love to hear from you.

The Role

This newly created role will be responsible for leading the quality assurance functions for Sabal Therapeutics and its client companies. This role will commence with an evaluation of company GMP Quality Systems and gap analysis. Creation and implementation of necessary processes and procedures will be an integral part of the first six months. Oversight of third party CMO activities, outsourced packaging facilities and API providers as well as on-going product release, change control, CAPA, employee training and vendor auditing are key functions of this position. The role holder will provide strategic leadership and coordination of these key functions to ensure that the short-term and long-term objectives of the company are met.

This is a hybrid role, based from Greenville, South Carolina.

Key Responsibilities

• Lead the Quality Assurance department in the development/revision and implementation of Standard Operating Procedures (SOPs) as required.
• Ensure compliance (GMP, GXP) with appropriate SOP's according to US FDA and ICH guidelines.
• Have contract manufacturer, packager, and analytical lab oversight.
• Batch release, product complaints, distribution records management.
• Change control administration and management as well as responsibility for the company's overall document control systems.
• Complete vendor audits.
• Manage complaints and investigation systems management.
• Ensure FDA and cGMP compliance across the organization.

Requirements

• Proven Quality leader with 5-10 years experience in the pharmaceutical or healthcare related industry.
• Bachelor's degree (or equivalent) in biological or health sciences. An advanced or additional business degree is desirable.
• 1-2+ years effectively managing and leading teams.
• Strong management and leadership skills along with strategic thinking ability and a proven track record of FDA and cGMP compliance.
• Self-motivated with a high degree of initiative and sense of urgency.
• Ability to work independently, prioritizes multiple projects, addresses multiple issues, and handles multiple deadlines, in a hands-on environment.
• Inter-dependent partnering skills, team-orientation and demonstrated ability to influence outcomes
• Solid decision-making skills.
• Excellent communications skills (verbal, written, listening, conveying messages) with strategizing and negotiating strengths.

We are committed to fostering an environment of enablement where our people can grow, develop their talents, and pursue meaningful career paths. By placing patients and customers at the heart of everything we do, we drive high performance through accountability, consistency, and a strong governance structure. We champion inclusion, community, and a rewarding employee experience—creating a culture that supports development, celebrates achievement, and empowers individuals to thrive.

Diversity & Inclusion is integral to our culture and reflecting the patients we serve. At Rosemont, we believe equal opportunity for all is fundamental to our company's values and all our applicants can expect fairness and transparency in our recruitment process.