Manager, Quality Assurance
Arranta Bio is a rapidly growing and dynamic bio-pharmaceutical contract development and manufacturing organization (CDMO). Our vision is to be the best in class CDMO providing development and GMP manufacturing services to microbiome innovators within the pharmaceutical industry. Therapies focused on the human microbiome are exhibiting incredible potential towards revolutionizing disease etiology and associated medical treatments. Arranta Bio’s mission is to build a world class organization which provides microbiome bio-pharmaceutical innovators with a single source of supply from early process development through clinical and commercial GMP finished product.
WHO ARE WE
Arranta hires people who are committed and passionate to the goal of bringing life enhancing products to patients. We want top talent who will render ideas and a relentless desire towards accomplishing our mission; when a job becomes a passion, it makes you feel ALIVE.
Here at Arranta Bio, we embrace ALIVE – our core values that we live and breathe daily! We are Agile, Leading, Innovating, Value Creating, and Engaging.
We embrace our challenges as opportunities.
We are empowered to think and act.
We never settle; we strive to improve through purposeful creativity.
We build aligned teams who learn, grow, and deliver.
We are committed to building strong relationships.
Are you ready to come ALIVE with a daring and intrepid team? Don’t wait another minute; Apply today!
The Manager of Quality Systems at Arranta Bio will support the development and implementation of quality systems for the Gainesville, FL facility to ensure compliance with US and international regulations, laws, and guidelines.? Reporting to the Site Head of Quality, the Manager will be accountable for building and managing quality systems including but not limited to training, documentation, deviation, CAPA, change control, quality metrics, and audits. This is an exciting opportunity to be responsible for building and shaping the quality systems for a greenfield commercial GMP manufacturing facility. This position will be based in Gainesville, FL.
• Building and manage the Quality Management System at Gainesville, FL.
• Manage the implementation and maintenance of electronic QMS systems such as those for Document Management, Training, LIMS, etc.
• Provide or support training of all GMP functional areas
• Coordinate and support the creation of and revisions to Standard Operating Procedures (SOPs)
• Develop and manage systems for control, handling, and storage of GMP documents
• Support Arranta Bio customers to ensure satisfaction and compliance for their clinical and commercial programs
• Develop GMP audit schedules, oversee execution of audit plans, track audit reporting and corrective/preventative actions
• Collect and report of quality metrics via Quality Management Reviews and the Quality Council
• Promote a Quality Culture
• Interface with other Arranta Bio locations to ensure consistency in Quality Systems
• Build and manage QA Systems staff and processes that will drive innovation, teamwork and efficiency within the organization
Experience and Skills
EDUCATION AND/ OR EXPERIENCE
- ?BS degree in life sciences, chemistry or minimum of 10 years of experience in Biotech or Pharma and 5+ years' experience in Quality management roles
- Ability to develop and implement GMP quality systems
- Knowledge of how to identify key quality metrics for maintaining compliance and identifying areas of improvement
- Understanding of domestic and international regulatory requirements
- Ability to effectively prioritize and manage multiple projects and tasks
- Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based decisions
- A team player, who listens effectively and invites response and discussion
- A collaborator who communicates in an open, clear, complete, timely and consistent manner
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- The employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear.
- The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
- The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
- Specific vision abilities required by this job include close vision, and ability to adjust focus.
- In the performance of the duties of this job the employee is required to travel occasionally, drive a motor vehicle.
- Communicate using telephone and e-mail.
- Phone reimbursement policy for qualified individuals
- Free parking
- Highly competitive healthcare with many plan options:
- Medical (HMO/PPO/EPO)
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Up to 10 weeks of 100% paid maternity leave
- 2 weeks of 100% paid paternity, domestic partner, & adoption leave
- Educational assistance program
- 401k (traditional and Roth offered) with 100% match on first 5% deferred.
- A suite of Arranta Bio paid insurance coverage, including life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- Employee Referral program
- Competitive PTO plan, in addition to 10 company paid holidays (includes 2 floating holidays)