Job Details

SUMMARY:

The Quality Manager strengthens, maintains, and improves the company's Quality Management System (QMS) to ensure compliance with applicable regulations and internal standards. This role provides quality oversight of external partners (e.g., CMOs, contract labs, service providers), supports regulatory readiness, and leads key quality system elements such as complaints, CAPA, change control, APRs, and metrics reporting. The Quality Manager works cross-functionally to resolve issues using data-driven methods and ensures consistent quality practices across the organization. This is a remote role with up to 20% travel to partner sites, audits, or business-critical meetings.

ESSENTIALFUNCTIONS:

Quality Systems Ownership

• Develop, revise, and implement SOPs and controlled documents.
• Ensure timely initiation, investigation, and closure of quality records (deviations, CAPAs, complaints, change controls).
• Maintain QMS compliance and support continuous improvement of quality processes.

External Partner Oversight

• Review and evaluate quality data and documentation from CMOs and other external partners.
• Participate in external audits and assessments; verify partner corrective actions and ensure alignment with quality agreements.

Compliance & Audits

• Conduct internal audits to verify compliance with relevant regulations and internal standards.
• Conduct supplier audits to ensure compliance with relevant regulations, including writing audit reports and determining appropriate corrective actions and effectiveness checks.
• Support regulatory inspections and maintain overall inspection readiness.
• Ensure adherence to applicable regulations relevant to contracted operations (e.g., cGMP, 21 CFR requirements).

Product Quality / Post-Market Surveillance

• Lead and document complaint investigations and adverse event assessments.
• Support product quality trending and contribute to Annual Product Reviews.

Metrics & Reporting

• Assemble, analyze, and present quality metrics and trends.
• Identify risk areas and improvement opportunities and contribute to Management Review inputs.

Continuous Improvement

• Apply root cause analysis tools (5 Why, Fishbone/Ishikawa, 8D) and risk management methods (FMEA).
• Support process improvements that enhance compliance, efficiency, and product quality.

Stakeholder Collaboration

• Serve as a QA interface with internal teams and external partners.
• Communicate findings, risks, quality expectations, and recommendations professionally and effectively.

KNOWLEDGE,SKILLSANDABILITIES:

• Strong working knowledge of QMS principles and GxP expectations applicable to contracted operations (e.g., 21 CFR Part 11; 21 CFR 210/211 or 820, depending on product type/partners).
• Proficiency with quality tools including root cause analysis, CAPA methodology, FMEA, and statistical analysis (MiniTab preferred).
• Excellent written and verbal communication skills, including clear technical reporting.
• Strong analytical and problem-solving skills; ability to manage multiple priorities independently.
• Ability to work cross-functionally and influence without authority.
• Proficiency with Microsoft Office and QMS platforms.

EDUCATION & EXPERIENCE:

• Required: Bachelor's degree in a scientific, engineering, or related discipline (or equivalent experience).
• Required: 5-7 years of experience in a regulated environment (pharmaceutical, biotech, medical device, or similar), including ownership of core QMS components (e.g., complaints, CAPA, change control, APRs).
• Desired: Internal/external audit experience; experience with external partners such as CMOs or contract labs.
• Desired Certifications: ASQ CQE, CQA, or equivalent.

WORKING ENVIRONMENT

• Remote/work-from-home with regular virtual collaboration.
• Standard home-office environment with prolonged periods of computer-based work.
• Travel up to 20% for partner visits, audits, or business-critical meetings.

THE COMPANY:

Aytu BioPharma is a specialty pharmaceutical company committed to improving the health and quality of life for patients everywhere. We develop and deliver unique prescription therapeutics that help people lead healthier, more fulfilling lives, with a distinct focus on complex central nervous system (CNS) conditions.

Our growing CNS portfolio includes treatments for major depressive disorder (MDD) and attention deficit-hyperactivity disorder (ADHD), supported by a legacy suite of products that address allergies and fluoride deficiency. Through our best-in-class patient support program, Aytu RxConnect, we ensure patients and providers receive exceptional access, affordability, and care.

At Aytu, we're driven by a patient-first mindset and a culture built on collaboration, accountability, and innovation. We empower our people to do meaningful work that makes a real impact-advancing therapies, improving patient access, and helping shape the future of CNS healthcare.

EQUAL OPPORTUNITY EMPLOYER

Aytu BioPharma is proud to be an Equal Employment Opportunity employer. We welcome applicants from all backgrounds and do not discriminate on the basis of race, color, religion, sex, national origin, age, disability, genetic information, or any other protected characteristic. We comply with all federal, state, and local employment laws. Employment decisions are based on qualifications, merit, and business need.