Director of Quality, Media Products
About the Company
Twice named one of the top 100 Companies to Work for in Washington State, we’re a life science tools provider and we enable customer development and commercialization of life-saving regenerative medicine cellular therapies. We welcome you to apply to join our dynamic, high-energy corporate culture. Here you will find a performance-based, family-oriented environment where authentic and respectful communication is required.
We develop, manufacture and market proprietary hypothermic storage and freeze media solutions for cells, tissues, and organs. Our platform of solutions is highly valued in the regenerative medicine, biobanking, and drug discovery markets. Public listing on the NASDAQ; ticker symbol BLFS. All team members have an opportunity to participate in our value creation by receiving stock options. Please visit our website https://www.biolifesolutions.com
General Summary and Purpose:
The Director of Quality, Media Products is a core team member of the BioLife Solutions Quality Team, Media Products. The Director of Quality Assurance, Media Products is responsible for creating, managing, continually improving and directing the Quality Management System for BioLife Solutions Media Products in accordance to ISO 13485 Standards. The Director of Quality also serves as the Management Representative of Quality. This position is responsible for ensuring all raw materials and finished goods are tested according to prescribed procedures and controlling for use only those tested to meet specifications and for leading, managing and coaching the Quality Assurance and Quality Control team.
Duties and Responsibilities:
- Validation and Qualification:
- Develops and manages the validation program.
- Supports new product development.
- Quality Assurance
- Owns, manages, continually improves and leads the development and implementation of quality system procedures and supporting documentation through the business operation.
- Ensures Quality Management System is compliant to ISO 13485 standards.
- Supports all site leadership to maintain compliance throughout the site operation.
- Trains all team members on the Quality Policy/Manual and Quality Management Systems, ensuring all team members perform work in accordance to these standards.
- Represents the company in a professional manner and uphold the highest interactions with other employees, customers, suppliers and third parties.
- Communicates Quality System status to the Company through management reviews, quality audits, post market surveillance and other quality management processes.
- Ensures all components, raw materials and finished goods are manufactured and released according to internal specifications and procedures.
- Assigns, reviews, and approves Corrective and Preventive Actions.
- Responds to customer feedback and investigates complaints.
- Supports customer requests for information in their regulatory/quality filings.
- Ensures qualification of all key suppliers.
- Oversees all validations, qualifications and verifications.
- Owns the internal audit and supplier audit program, ensuring only suppliers appropriate for use are qualified.
- Hosts on-site customer audits, conducts supplier and internal department audits.
- Ensures change is implemented in a controlled fashion.
- Ensures new products are designed and developed in accordance to ISO 13485 requirements.
- Oversees media related risk management.
- Quality Control
- Ensures raw materials, products and finished goods are tested using validated procedures, calibrated equipment, and according to written procedures
- Oversees company stability program.
- Team Member Management
- Directs daily tasks of the Quality Control and Quality Assurance Personnel
- Leads, manages and coaches all members of the Quality Team
- Ensures effective development and performance feedback of each member of the Quality Team
- Recruits and trains members of the Quality Team.
- Ensure resource levels are sufficient to support business requirements.
- Maintains an engaged Quality Team
- Effectively recruits, on boards and trains new team members.
- Other As needed
- Ensures budgets and schedules are developed, established and achieved.
- Supports cross business projects as assigned.
- Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
The Director of Quality Assurance, Media Products reports directly to the Senior Vice President/Chief Quality Officer.
All members of the Quality Assurance Team, Media Products, report directly into this position.
The Head of Quality Control, Media Products, reports directly into this position.
- Knowledgeable about and experience with compliance to cGMP and ISO 13485 Quality Management Systems
- Experience overseeing the Quality Program for an Aseptic Fill Operation
- Experience writing validation studies and interpreting results.
- Experience with basic statistical analysis.
- Ability to display assertiveness paired with empathy and diplomacy.
- Ability to build a work culture of mutual trust.
- Ability to creatively collaborate with team members
- Proficient in Microsoft Office programs.
- Excellent written and verbal communication skills.
- Ability to lead, manage and coach team members.
- Ability to effectively manage multiple priorities with challenging timelines.
- High integrity
- Able to use sound judgement and reasoning to solve daily tactical issues
- Must be able to make strategic contributions to the company
- A minimum of a bachelor’s degree in in Biological or Chemical related curriculum with 7+ years experience working in Quality Assurance with a minimum of 3 years working in medical device QA/RA.
- A minimum of two years leading, managing and coaching a team.
- Affiliation with Quality Professional Organization(s) such as ASQ and associated certifications (CQM/OE, CQE, etc) desired.
- Data management and basic statistics
“BioLife Solutions provides a substance-free workplace and all offers of employment will be contingent on opiate drug test.”
BioLife Solutions is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.