Manager, Compliance at Austin
Who Are We?
Powered by technology and compassionate design, Parachute has reimagined the plasma donation experience into one that is easier and friendlier. Using a simple app, our members can book donations and track earnings from the palm of their hand. In using a tech-forward approach, we’re able to offer each member a highly personable and best-in-class experience that’s consistent at each and every visit.
Our vision is to introduce an elevated plasma donation experience grounded in convenience to markets with smaller populations. This model allows us to positively impact the industry supply chain and help patients gain access to the medication they need.
Come join us as we help the world gain access to more plasma - one donation at a time.
What You’ll Do
A Compliance Audits Manager is responsible for quality assurance and regulatory functions. The creation, maintaining and conducting of company audits. Process review for regulated departments within the organization and prepare written reports of identified deficiencies. Completes documents required for compliance and regulatory submissions participates in internal and external inspections and provides regulatory compliance guidance to personnel. This role is intrinsically linked to Parachute’s donor-centric mission, and you will have an opportunity to be a part of an agile, passionate, and fast-growing team.
Essential Functions and Expectations
- Understand all applicable plasma donation processes from registration through product shipment to a subject matter expert (SME) level.
- Understand applicable operation processes as they apply to quality assurance compliance and quality control requirements to a Subject Matter Expert level.
- Verifies and identifies plasma regulations, i.e., PPTA, EMA, and FDA.
- Creates, establishes, and conducts audits representing the company.
- Identifies and assesses risks, trends, and incorporates them within audit protocol.
- Prepares written reports from inspection/audit findings, evaluates corrective actions, and reviews for proper response and closure.
- Participates in preparation for regulatory and accrediting inspections and provides support during the inspection process.
- Identifies focus areas for improvement and recommends changes for company compliance and improvement.
- Assists in the tracking and monitoring of quality trending and established quality KPIs.
- Assists in Nonconformance CAPA management deviation trending.
- Assists in identifying local and state regulatory requirements.
Who Are You?
- In-depth experience in the entire audit management process.
- Knowledgeable in plasma/blood banking or a similar regulated environment.
- Superior analytical, technical writing, and composition skills.
- Enthusiastic, fast-paced, self-starter.
- Superior attention to detail.
- Lifelong learner with a growth mindset.
- Ability to work under pressure; meet inflexible deadlines; set priorities; deal diplomatically with challenging individuals, manage multiple workflows, and work independently. Adherence to the highest ethical standards is essential.
- Bachelors in a science or related field.
- At least 2 years of quality assurance experience in plasma/blood banking or a similar regulated environment
- At least 2 years of experience in auditing and issuing audit responses for plasma/blood banking or a similar regulated environment
- Willing to travel 50% of the time or more as needed
- Certified Quality Auditor (CQA) certification
- Project management & process improvement experience
- Established knowledge of applicable CFR & EU standards for plasma
- Competitive compensation
- Medical, Dental, and Vision insurance
- Paid time off
- HSA and Dependent Care Flex Spending
- Career growth opportunities