Job Summary
 

The Senior Manager, Safety and Quality will play a critical role in ensuring Alto’s supply chain and manufacturing partners meet the highest standards of patient safety, regulatory compliance, and product quality. This leader will oversee safety and quality programs across our manufacturing relations and supply chain network, drive continuous improvement, and act as a liaison between internal teams, external partners, and regulatory bodies.

Job Description
 

Accelerate Your Career as You

Safety & Compliance

• Develop, implement, and manage safety protocols across supply chain and manufacturing operations.

• Ensure compliance with FDA, DEA, and state pharmacy regulations, as well as internal company standards.

• Lead audits and inspections, both internal and external, to verify adherence to safety and quality requirements. 

Quality Management

• Own Alto’s quality management systems (QMS) related to supply chain and manufacturing partners.

• Establish KPIs and reporting mechanisms to track supplier quality, recalls, deviations, and corrective/preventive actions (CAPA).

• Partner with manufacturing and logistics teams to resolve quality issues and prevent recurrence.

• Manage product investigations, complaints, and adverse event reporting in coordination with regulatory teams.

Supplier & Partner Relations

• Build strong partnerships with external manufacturers, distributors, and vendors to ensure alignment on safety and quality standards.

• Conduct supplier risk assessments and qualification programs, including routine monitoring and re-certifications.

• Support contract negotiations by providing input on safety and quality clauses.

Leadership & Collaboration

• Collaborate cross-functionally with Supply Chain, Manufacturing Relations, Operations, Pharmacy, and Regulatory Affairs teams.

• Provide guidance and training to internal stakeholders on quality and safety best practices.

• Mentor and develop team members as Alto scales its supply chain and manufacturing partnerships.

A Bit About You

Minimum Qualifications:

• Graduate of an accredited school of pharmacy and a Licensed Pharmacist (RPh) in good standing with the State Board of Pharmacy in the state where the pharmacy site is located and also in good standing for any Non Resident Licenses as dictated by business strategy.

• 3+ years of management experience in quality, safety, or compliance functions.

• 5+ years of progressive individual experience in pharmaceutical, biotech, or healthcare supply chain quality assurance.

• Strong knowledge of FDA, DEA, cGMP, and state pharmacy regulations.

• Experience conducting audits, managing CAPAs, and implementing QMS processes.

• Strong collaboration skills with the ability to partner across supply chain, operations, and regulatory teams.

• Proficiency in standard tools and systems such as GSuite, Slack, and digital quality management systems.

• Excellent organizational and communication skills, with proven ability to influence stakeholders and vendors.

Preferred Qualifications: 

• Experience with pharmacy operations, distribution, or manufacturing relations.

• Familiarity with Lean, Six Sigma, or other continuous improvement methodologies.

• Demonstrated success scaling safety and quality programs in a growth-stage organization.

Additional Information
 

Additional Physical Job Requirements

This position requires occasional travel therefore you must be able to sit for extended periods of time on airplanes and/or in vehicles, lift and carry luggage independently, navigate long distances through airports and other travel locations independently, and adjust to different time zones and climates.

Physical requirements for this role include the ability to work at a computer terminal with monitor, keyboard and mouse for extended periods of time, stoop, bend, and reach for equipment and supplies, make frequent repetitive motions required to operate a computer that include the wrists, hands and fingers, and lift, carry, push, pull, and move light objects up to 20 pounds. The role also requires the ability