Head of Quality, Alachua

Ology Bioservices, Inc.
Job Description
DESCRIPTION

Summary:

The Head of Quality-Alachua is accountable for the quality oversight of the GMP operations at the manufacturing plant located in Alachua, Florida. This is an exciting opportunity to oversee the ongoing GMP operations and to lead the site through the facility expansion and transition from clinical to commercial GMP operations. The Head of Quality is a key leadership role and reports to the Chief Quality Officer.

Responsibilities:

  • Oversees the GMP operations at the Alachua manufacturing plant and ensures adherence to applicable laws and regulations, corporate policies/standards, and Client requirements
  • Accountable for site processes and procedures in order to successfully fulfill the responsibilities for Quality Assurance, Quality Control, Quality Systems and Compliance
  • Accountable for recruiting talent and building a high performance Quality team. Mentors and develops personnel and ensures team's agility, versatility and expertise redundancy.
  • Collaborates with other Quality leaders and Resilience network stakeholders and assists in the implementation, continuous improvement and lifecycle management of GMP policies, standards and quality management system
  • Oversees and/or contributes to the development and execution of Quality Agreements with Clients. Accountable for the timely and compliant delivery of site's responsibilities in accordance with the Quality Agreement requirements.
  • Accountable for product disposition to Clients. Assures timely notification, investigation and mitigation of quality events.
  • Accountable for timely notification and effective management of internal and Client-related changes
  • Leads site audit and regulatory inspection readiness plan. Leads and hosts Client audits and regulatory inspections. Ensures timely and compliant responses and resolution of identified deficiencies.
  • Manages effectively the site's GMP training program. Champions initiatives for continued learning and development.
  • Represents site Quality in corporate planning and joint Client-Resilience forums, as applicable
  • Prepares and hosts periodic site Quality Management Reviews to assess the health of the Quality Systems and collaborates with stakeholders to ensure identified improvements. Contributes to the periodic corporate Quality
POSITION REQUIREMENTS

Preferred Qualifications

  • Comprehensive knowledge of global GMP regulatory requirements for biologics and vaccine products
  • Hands-on experience with overseeing GMP operations at a biologics or vaccines manufacturing plant is required
  • Experience with transition of manufacturing operations from clinical to commercialization phase is required
  • Experience with facility commissioning and qualification is required
  • Experience with managing regulatory agency inspections is required
  • Proven record with building high performance Quality teams
  • Excellent oral and written communication skills
  • Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward
  • Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence
  • Bachelor’s degree or higher in Life Sciences, Chemistry, Engineering, or related field
  • Minimum of 18 years of biotechnology industry experience, with minimum of 7 years in a Quality leadership role
NUMBER OF OPENINGS 1  
EOE STATEMENT Ology Bioservices,is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, gender,sexual orientation, gender identity, age, physical or mental disability, genetic factors, or military/veteran status or any other characteristics protected by law.

EEO Minorities/Women/Disabled/Veterans  
ABOUT THE ORGANIZATION Thank you for your interest in joining the Ology Bioservices team! We believe we have the most talented and committed employees in the industry with decades of combined experience in manufacturing, developing and licensing vaccines and protein/antibody therapeutics.
Ology Bioservices is a full-service Contract Development Manufacturing Organization specializing in biologic drug substance manufacturing from early stage through commercial product. The company has 183,000 square feet of manufacturing, process development and QA/QC space in our state of the art Advanced Development and Manufacturing ADM) facility in Florida. Ology Bio has 20 years of experience developing and manufacturing drugs and biologics for the US Government, and over $500M in government contracts awarded over that time.
The company expanded to Commercial Manufacturing upon the move into the new facility in early 2017. Our infrastructure provides unique services to our clients, including full regulatory support from preclinical through licensure, clinical trial operational support and bioanalytical testing, as well as cGMP manufacturing up to Biosafety Level 3 (BSL3).
We offer outstanding career growth opportunities, excellent fringe benefits, and competitive pay.
We are an Equal opportunity Employer
AA/EEO Minorities/Women/Disabled/Veterans  
POSITION Head of Quality, Alachua  
LOCATION Alachua  
Contact Information