Job Overview: The Quality Systems & Operations Manager is a decisive, high-accountability leader responsible for ensuring daily quality execution within a regulated birth tissue processing environment. This role owns operational quality performance & systems compliance, drives procedural adherence, enforces standards without exception, and builds a culture of discipline, compliance, and ownership.
This individual does not avoid difficult conversations. They lead from the front, address performance gaps directly, hold team members accountable to documented standards, and ensure quality system integrity is never compromised for convenience.
Essential Functions:
Operational Quality Leadership
- Oversee day-to-day quality operations including:
- Incoming Receipt of Supplies/ Materials
- Quality Review of Manufacturing Batch record review
- Quality Final Release of Finished Products
- Management of the Quarantined products and supplies (QAHold Cage)
- Oversight of quality system including:
- Quality Events (Exception Requests, NCRs, Complaints, CAPAs, MRDs, etc.)
- Internal & Supplier Auditing
- Document Control
- Ensure all activities are performed per controlled procedures and documented in real time.
- Immediately address and correct deviations from SOPs.
- Track, trend and report metrics for the Quality Systems & Operations Team
- Record Retention of all Quality Generated documentation for the Quality System & Operations Team
Accountability & Performance Management
- Set clear expectations and measurable performance standards for Quality Systems & Operations staff.
- Address underperformance, procedural shortcuts, and behavioral issues promptly and professionally.
- Conduct routine performance coaching, corrective counseling, and performance documentation when necessary.
- Partner with HR to manage progressive discipline when required.
- Build a culture where compliance is non-negotiable.
QMS Execution & Enforcement
- Ensure:
- Nonconformances are documented timely
- CAPAs are implemented effectively
- Root cause investigations are thorough and evidence-based
- Monitor trends and proactively mitigate risk.
- Ensure strict adherence to document control processes (MasterControl or equivalent).
- Prevent use of obsolete forms and uncontrolled documents.
Inspection & Audit Readiness
- Maintain a constant state of inspection readiness.
- Lead preparation for:
- FDA inspections
- AATB inspections
- Internal audits
- Support responses to audit findings and ensure sustainable corrective actions.
Cross-Functional Influence
- Partner with Processing, Distribution, Supply Chain, and Executive Leadership.
- Communicate all risks to the Quality decision-maker when non-compliance is present.
- Escalate organizational risk appropriately and without hesitation.
Leadership Competencies
We are seeking a leader who demonstrates:
- Courageous leadership – willing to address difficult employees and noncompliance directly.
- Emotional intelligence – firm but professional.
- Decisiveness – makes sound decisions under regulatory pressure.
- Bias for action – does not allow issues to linger.
- High standards – expects procedural adherence without exception.
- Integrity – prioritizes patient safety and regulatory compliance above convenience.
* This job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the job. Other duties may be assigned.
Qualifications:
Required
· Bachelor’s degree in Life Sciences or related field
· 5+ years experience in:
o HCT/P (21 CFR 1271) OR
o Medical device (21 CFR 820 / ISO 13485) OR
o Biologics manufacturing
· 3+ years in a supervisory or management role
· Strong working knowledge of:
o FDA regulatory requirements
o AATB Standards (preferred)
o CAPA systems
o Root cause analysis
o Audit management
Preferred
· Experience in birth tissue processing or tissue banking
· Experience leading teams through FDA or AATB inspections
· Six Sigma or Lean certification
· MasterControl or equivalent eQMS experience
Location: On-Site – Mesa, AZ
What we offer:
Looking for a company to work for can be a daunting task, but we believe that we stand out from the rest. Our company offers a positive and inclusive work environment, opportunities for growth and development, and a commitment to work-life balance. Join us and become part of a team that values your contributions and invests in your success
Total Rewards Package:
· Competitive Salaries
· Health, Dental, and Vision Insurance
· Retirement Plans
· Tuition Reimbursement
· Generous Paid Time Off
· Employee Assistance Program
BioLab Holdings is an Equal Opportunity employer and does not discriminate based on race, ancestry, color, religion, sex, age, marital status, sexual orientation, national origin, medical condition, disability, veteran status, gender identity, or any other basis protected by law.