This position is open to remote applicants. 

Kaléo has secured multiple contracts with the U.S. government for the development and production of new medical countermeasures, with commercialization opportunities to follow. We are expanding our Quality team to facilitate this growth. 

The Senior Specialist, Quality Systems & Audits will manage, maintain, monitor, and make recommendations with regard to Kaléo’s quality management system, operated in MasterControl, and audit program for the Development and Operations organization, interacting with the entire organization and cultivating key relationships to achieve quality and compliance initiatives and goals.

This individual will work as part of a highly motivated Quality Assurance team where the patient is our focus and quality and compliance are #1. This is a team where learning, innovation, and professional growth are encouraged and supported.

As Senior Specialist, Quality Systems & Audits, you will:

• Actively interact with and support Quality Assurance activities related to manufacturing of Kaléo’s traditional life-saving products and of development and approval of medical countermeasures.
• Execute, manage, and maintain the quality management systems, ensuring overall conduct, record disposition, quality, policies, and procedures are adequate and consistently maintained.
• Own QMS Education & Training -Training end users to ensure proper navigation and data entry into the electronic quality management system. This includes creating and delivering procedural, system level, on-the-job, web-based, and GxP training,as necessary.​
• Manage Deviations and Quality Events - Conduct intake and verification of Quality Events, lead root cause investigations ensuring adequate cross-functional collaboration, and facilitate timely closure and escalation to CAPA.
• Facilitate Corrective and Preventative Action Investigations (CAPA) - Lead cross functional CAPA team to identify and implement durable CAPA plans.
• Manage Product Complaints - Working closely with Pharmacovigilance, complete intake approval, investigation approval, and resolution approval of Product Complaints. Lead investigations for confirmed Product Complaints and facilitate timely reporting and follow-up with regulatory authorities.
• Own Change Control -Assist in reviewing proposed changes to systems, procedures, methods, and submissions to regulatory agencies.
• Own Supplier Quality Management - Write, edit, review, and gain cross functional approval on annual Risk and Qualification Assessments, Investigations, Impact Assessments, Quality Agreements, Audit Reports, and Supplier Notifications for Contract Manufacturing Organizations (CMO), Contract Research Organizations (CRO), and other suppliers to ensure a status of ongoing compliance to regulations and contractual obligations, including Quality Agreements, with Kaléo. Maintain the Approved Supplier List.
• Lead Audit Program - Coordinate, maintain, and communicate the annual audit schedule working with internal stakeholders and external suppliers, conduct Internal Audits and Supplier Audits as assigned, write clear and concise audit reports, issue audit observations, collaborate on adequacy of audit response.
• Own Metrics Management - Maintain standardized system inputs to MasterControl and collect and report data for monthly quality metrics meetings. Establish and report supplier quality metrics for GMP-related functional areas for both internal contractors and contract manufacturers. Collect and escalate data for quarterly KPI Review and Management Review to management personnel, making recommendations regarding any indicated signals or trends.
• Foster Continuous Improvement: Identify, assess, and recommend remediation ideas regarding current and previous quality system risks and compliance​ gaps, including facilitating cross-functional gap assessments and development of Quality Plans. Partner with​ key stakeholders across the Development and Operations organization to execute on program improvements and plans.​

Additional assignments include:

• Write, edit, review, and gain cross-functional approval for controlled documents and records, including standard operating procedures and work instructions for Quality Systems and Audit Programs.
• Work collaboratively with both internal and external partners to resolve quality system issues​ and maintain GMP compliance, including facilitation of Annual Product Quality Review (APQR) report assembly and executive summary publication.​
• Support activities related to FDA and marketing partners regarding quality issues, including Field Alerts, Recalls, and/or regulatory actions.​
• Facilitate the Regulatory Intelligence Program reviewing current regulatory expectations and industry trends, communicating impactful updates to quality business unit Director.​
• Actively participate in regulatory inspections and audits from regulatory authorities, including response and remediation plans.​
• Work collaboratively with both internal and external partners to mitigate and resolve quality issues and maintain GMP compliance at Kaléo and Supplier sites.​
• Create and maintain strategic partnerships internally and externally.

A successful Senior Specialist, Quality Systems & Audits will have:

• Excellent communication skills, with the ability to interact with confidence at all levels of an organization and with external partners. Strong leadership skills, including the ability to influence with or without authority.
• Ability to work independently and make decisions, but with the judgment to know the situations where supervisory input is essential.
• Extensive knowledge and practical application of guidelines and regulations that govern GxP regulated activity.
• Proficient in orchestrating and navigating multiple priorities, with a demonstrated track record of executing strategic plans and achieving critical outcomes.
• Experience with, or direct knowledge of, quality system elements (e.g., complaints, change control, deviation, CAPA, standards and systems management, quality policy and procedures, Annual Product Quality Review, compliance related field actions, alerts, and similar events).
• A proven track record of participating in cross-functional teams to achieve significant quality system improvements.
• Ability to thrive in a fast-paced environment and manage competing priorities.
• Robust intellectual curiosity and desire to be part of an innovative organization.
• Commitment to contributing to and participating in an inclusive environment.
• Demonstrated planning and negotiation skills.

To be considered for the position, you must have:

• Bachelor's degree in the sciences is preferred and/or combination of relevant education and applicable experience will be considered.
• 5 years of progressively responsible Quality and/or Compliance related experience within the regulated pharmaceutical and/or medical device industry.
• Working knowledge with aseptic manufacturing operations regulations and guidelines.
• Knowledge and experience with risk-based approaches to Quality System implementation.
• Thorough knowledge of best practices in quality system management in pharmaceutical/medical device and other relevant industries.
• Experience with regulatory inspections/audits with regulatory authorities and notified bodies.
• Experience with electronic Quality Management Systems and similar technology.
• Knowledge and understanding of Title 21 Code of Federal Regulations Part 4, 11, 820, 210, 211, and ISO 13485 and 14971.
• Ability to travel overnight up to 25%. 

Additional preferred qualifications:

• Experience with MasterControl® is preferred.
• Certified in a Quality relevant Body of Knowledge, or similar credentials preferred.

Please complete candidate application for consideration. Additional questions can be directed to talentacquisition@kaleo.com.