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Vice President of Quality Assurance

4 weeks ago

Arizona City, Arizona, United States BioLab Sciences Full time

Job Title: Vice President of Quality Assurance

Company Summary:

BioLab Sciences is a regenerative health company focused on providing innovative solutions that encourage the body to heal naturally. Our mission is to manufacture reliable and safe products with the highest quality to help optimize body performance through continuous innovation, education, superior customer service, and teamwork. Since its founding, BioLab Sciences has experienced explosive growth and is actively developing new technologies to innovate, improve the customer experience, and expand its market share within the wound management space. We are seeking individuals who are passionate about making a difference in the work they do and will help support our company's mission.

Reports To:

Chief Executive Officer (CEO)

Job Overview:

As Vice President of Quality Assurance, you will oversee the Quality Assurance (QA), Quality Control (QC), and Quality Engineering functions for BioLab Sciences' products and operations, spanning both pre- and post-market activities. In this executive leadership role, you will develop and implement a robust global quality strategy to ensure compliance with all regulatory requirements and industry standards. Your leadership will drive a culture of quality excellence, support initiatives, and align the QA function with BioLab's strategic goals.

This position will play a critical role in building and maintaining a strong Quality Management System (QMS) while collaborating with cross-functional teams to support product innovation, regulatory submissions, and operational excellence. Additionally, you will lead the transformation of the organization to include medical devices regulated under harmonized ISO 13485 standards while maintaining compliance with 21 CFR 1271 and Section 361 for existing products. The ideal candidate will have deep experience in design and development efforts for medical devices governed under design controls, specifically as outlined in 21 CFR 820.30, and will have actively participated in the development of these systems.

Essential Functions:

Strategic Leadership:

  • Develop and execute a comprehensive quality strategy aligned with BioLab Sciences' corporate objectives and regulatory requirements.
  • Establish and drive a culture of quality excellence and continuous improvement across the organization.
  • Lead the organizational transformation to support medical devices regulated under ISO 13485, ensuring seamless integration with existing regulatory frameworks.
  • Develop long-term plans for QA/QC staffing and infrastructure to align with growth forecasts and strategic priorities.
  • Develop and administer budgets, plans, and performance requirements linked to the quality Assurance and Quality Control departments
  • Create a comprehensive Quality Plan with clear deliverables, including performance metrics.

Regulatory Compliance:

  • Ensure compliance with global regulatory standards, including FDA, 21 CFR 1271, 21 CFR 820.30 (design controls), and ISO 13485.
  • Oversee the design, implementation, and maintenance of BioLab Sciences' Quality Management Systems (QMS).
  • Lead regulatory inspections, audits, and interactions, ensuring timely and accurate responses to regulatory bodies.
  • Stay informed on changing regulations and proactively update internal processes to maintain compliance.
  • Collaborate with cross-functional teams, including Product and Process Development, Manufacturing Operations, Facilities Engineering, Supply Chain and Environmental Health and Safety, to ensure seamless integration of quality processes throughout the product life cycle in alignment with GMP requirements

Operational Excellence:

  • Oversee QA/QC activities to ensure product quality, safety, and compliance throughout the product lifecycle across distinct business processes.
  • Manage GMP activities, ensuring compliance in manufacturing operations and product release processes.
  • Develop and track key performance indicators (KPIs) for quality, ensuring actionable insights and continuous improvement initiatives.

Team Leadership and Development:

  • Build, manage, and mentor a high-performing quality assurance team, ensuring alignment with company goals.
  • Foster a culture of accountability, collaboration, and professional development within the QA function.
  • Ensure all QA team members are trained and equipped to uphold the highest standards of compliance and quality.

Risk Management:

  • Develop and implement a risk-based approach to quality assurance and quality control processes.
  • Deploy new business processes integrated into design controls, ISO 13485, ISO 14971, and other critical but relevant standards.
  • Ensure the implementation of ISO 14971 for risk management throughout the product lifecycle.
  • Proactively identify risks, develop mitigation strategies, and implement corrective and preventive actions (CAPAs).

* 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:

Education:

  • Bachelor's degree in Life Sciences, Engineering, or a related field is required; a postgraduate degree in Engineering or Life Sciences is preferred.

Experience:

  • Minimum of 15 years of experience in Quality Assurance, with at least 5 years in a senior leadership role in the pharmaceutical, biotech, or medical device industry.
  • Proven track record in developing and executing global QA strategies.
  • Extensive experience with GMP, GLP, 21 CFR 1271, 21 CFR 820.30 (design controls), ISO 13485, ISO 14971, and international regulatory requirements.
  • Demonstrated success in regulatory inspections and audits.
  • Experience leading QA functions in both clinical and commercial settings is highly desirable.

Leadership Skills:

  • Strong ability to influence and lead cross-functional teams.
  • Proven experience in building and mentoring high-performing teams.
  • Collaborative leadership style with excellent interpersonal and communication skills.

Technical Skills:

  • Expertise in quality management systems and risk-based approaches to QA/QC.
  • Proficient in using quality metrics and data analysis to drive decision-making.
  • Knowledge of quality improvement methodologies, such as Lean or Six Sigma.
  • Strong analytical and problem-solving skills, with a proactive and results-oriented mindset.

Other Requirements:

  • Highly diplomatic, ethical, and honest in all professional interactions.
  • Ability to prioritize and manage multiple projects simultaneously in a fast-paced environment.
  • Willingness to travel up to 15%, as needed.

Key Deliverables:

  • A comprehensive Quality Plan and KPIs for QA/QC functions.
  • A robust Quality Management System that meets regulatory and business needs.
  • Successful transformation to include ISO 13485 compliance for medical devices while maintaining compliance with 21 CFR 1271.
  • Timely and successful completion of regulatory inspections and audits.
  • Metrics showing continuous improvement in quality processes and team performance.
  • Established risk management framework for QA/QC operations.
  • A clearly delineated core competency matrix identifying strategic competencies needed, an associated department structure, and a plan to evolve and build the team accordingly.

Location:

On-site – Mesa, AZ.

What We Offer:

  • Competitive Salaries
  • Health, Dental, and Vision Insurance
  • Retirement Plans
  • Tuition Reimbursement
  • Generous Paid Time Off
  • Employee Assistance Program
  • No Premium Payments

BioLab Sciences 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.