Director, Quality Systems Management

Tyra Biosciences, Inc. is seeking a highly motivated Director of Quality Systems Management to make impactful contributions to oncology and rare disease drug discovery projects targeting disease areas with high unmet medical need. The successful candidate will be highly organized, self-motivated, and thrive in a dynamic, cross-functional start-up environment.

The Director, Quality Systems Management is responsible for hands-on and strategic oversight of Quality Systems at Tyra of electronic Quality Management System (eQMS), document management, training, and vendor management. This pivotal role will define the quality systems strategy for our evolving pipeline by implementing a scalable QMS framework that ensures GxP compliance (GMP/GLP/GCP) while fostering an environment of innovation.

The Director, Quality Systems Management will be responsible to help build, implement, and maintain a robust, phase-appropriate QMS, including SOP governance, training, deviation management, CAPA and vendor oversight while partnering with cross-functional Subject Matter Experts (SMEs) from all GxP associated departments. This role will also be responsible to help develop meaningful metrics to be communicated across the organization on quality systems compliance on a regular basis.

Job Responsibilities:

• Document Management SME, training/assisting personnel with eQMS workflows and supporting controlled document processes for new, revised, and released documents ensuring compliance with company-controlled documentation procedures and regulatory requirements.
• Edit and proofread controlled documents for consistency of document format and adherence to Quality Management Systems processes and procedures.
• Maintain training curricula and administer the training system to ensure the required training is assigned for all employees who have responsibility or accountability for GxPs.
• Support and advise end-users on eQMS requirements and workflows.
• Support end-user execution within the eQMS so that regulated documents are clear, concise, and consistently formatted.
• Support and monitor eQMS documentation control processes and systems including:

o Build training assessments into training compliance requirements

o Notify departments of new/revised document effective dates

o Create and manage enterprise-wide document templates

o Oversee schedule for documentation review within eQMS

• Create and revise document management-related procedures as needed.
• Track and report on in-progress controlled documents to ensure edits, reviews, and approvals are completed within the eQMS.
• Provide compliance metrics to upper management
• Facilitate and track compliance for study-specific training assignments, working with Clinical Trial Managers as team rosters change and/or when new documents need to be assigned and/or assigned documents must be archived.
• Provide new hire/onboarding training relating to the procedures and compliance with the use of the eQMS.
• Collaborate with HR/IT to ensure new hire and promoted team members have current JD/CV in the eQMS.
• On-board, off-board employees in the eQMS.
• Troubleshoot issues related to document management and eQMS training and support implementation of effective solutions and corrective actions.
• Support configuration changes, training improvements, and efficiency opportunities, for continuous improvement.
• Participate in software system upgrade activities, such as testing and validation.
• Identify and drive continuous improvements to the eQMS for process efficiencies and improved compliance.
• Coordinate organize Management Review materials
• Drive internal inspection readiness activities in preparation for potential regulatory health authority inspections.
• Oversee the management of vendors and supplier qualification and documentation

Qualifications:

• Bachelor's Degree and 10 years of successful quality assurance or quality systems related experience
• Understanding of GxP regulations and current industry practices
• Comprehensive knowledge of quality principles and systems, audit, manufacturing processes, procedures, and equipment within a pharmaceutical biologic environment
• Demonstrated critical problem-solving skills with ability to coordinate process improvement initiatives and quality system related projects with high level / wide scope and complexity
• Demonstrated ability to effectively communicate information and ideas to interact effectively with peers, senior management, regulatory officials, auditors, contractors and consultants
• Knowledge of computer software, including relevant applications such as MS Word, Excel, PowerPoint, SharePoint
• Experience with managing company-wide electronic QMS
• Advanced experience using Microsoft Word, Excel, PowerPoint, PowerBI
• Experience using an electronic document management system (e.g., MasterControl, Veeva, Trackwise, etc.)
• Enhanced knowledge of GxP concepts and guidelines
• Ability to work independently and as an effective and engaged team member in a fast-paced environment
• Superior communication skills both written and verbal with staff at all levels of the company enterprise wide
• Strong initiative, follow through, and attention to detail
• Ability to balance both strategic and tactical responsibilities
• Ability to work well in a deadline-driven environment and be flexible in a dynamic environment
• Experience in a fast-paced, agile biotech environment
• Excellent attention to detail
• Ability to effectively communicate and share knowledge with cross-functional teams
• Proven ability to work under tight deadlines and pressure
• Must be highly organized and efficient to manage multiple tasks

Pay Range and Benefits

Base Salary Range: $221,334 - $277,560 USD

Individual compensation will be determined based on factors such as work location, skills, education, training, and experience.

What we offer US-based Employees:

• Competitive base, bonus, new hire and ongoing equity packages
• The starting compensation range(s) for this role is for a full-time employee (FTE) basis
• Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment
• Employer-paid Medical, dental, and vision insurance
• Employer-paid life insurance, AD&D, short-term disability, long-term disability, and EAP coverage
• 401(k) Plan with a fully vested company match 1:1 up to 4% of contributions
• Employee Stock Purchase Plan
• 14 -18 paid holidays, including office closure between December 25th and January 1st
• Flexible vacation
• Sick time
• Fitness Program
• Get Outdoors Program
• Paid parental leave benefit
• Tuition assistance

Job Type: Full-Time

Work authorization: United States (Required)

Work Location: Remote

Equal Opportunity Employer: Tyra Biosciences, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.

Notice to Recruiters and Third-Party Agencies: The Talent Acquisition team manages the recruitment and employment process for Tyra. To protect the interests of all parties involved, Tyra will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Tyra employees directly in an attempt to present candidates. Tyra will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.