BioLife Solutions is repeatedly named one of Washington’s 100 Best Companies to Work For, a list curated by Seattle Business Magazine. We welcome you to apply to join our dynamic, high-energy team. Here you will find a performance-based, family-oriented environment where authentic communication and treating colleagues with respect are required. Our employees receive a competitive benefits package, which includes generous company stock awards and a 401k matching program.

BioLife Solutions is a leading developer, manufacturer and supplier of class-defining cell and gene therapy bioproduction tools and services. Our solutions facilitate basic and applied research and commercialization of new therapies by maintaining the health of biologic source material and finished products during manufacturing, storage, and distribution. Our solutions offer commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of biologic materials. Our tools portfolio includes our proprietary, serum-free and protein-free, fully defined CryoStor® freeze media and HypoThermosol® shipping and storage media, ThawSTAR® family of automated, water-free thawing products, evo® cold chain management system, and Custom Biogenic Systems high-capacity storage freezers. Services include SciSafe biologic and pharmaceutical materials storage. For more information, please visit: www.biolifesolutions.com

General Summary and Purpose:

The Senior Director of Global Quality Assurance and Regulatory Affairs, Storage Platform is responsible for creating, managing, continually improving and directing the Quality Management System and Global Regulatory Affairs Compliance for BioLife Solutions storage service platform in accordance to CBER/CDER, Eudralex and Good Distribution Practices regulations. The Senior Director of Global Quality Assurance and Regulatory Affairs serves as the Management Representative of Quality and Authorized Authority for International Regulatory matters. This position is responsible for ensuring all product accessioning, storage and retrieval services are conducted in accordance to prescribed client agreements, procedures, policies, and regulations and for leading, managing and coaching the Quality Assurance team at all storage locations.

Duties and Responsibilities:

New Site Expansion: 15%

• Serves as core team member on new product/service offering development teams as ensuring product meets all quality and regulatory requirements.
• Develops and manages the validation program.

Quality Assurance 35%

• Owns, manages, continually improves, and leads the development and implementation of quality system procedures and supporting documentation through the business operations
• 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 service offerings are delivered according to internal specifications and procedures.
• Assigns, reviews, and approves Corrective and Preventive Actions.
• Serves as Management Representative for Quality.
• Responds to customer feedback and investigates complaints.
• Supports customer requests for information in their regulatory/quality filings.
• Ensures qualification of all key suppliers.
• 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 services are designed and developed in accordance to regulatory and standards requirements.
• Oversees risk management program.

• Regulatory Affairs 35%
• Ensures Quality Management System and Operational Management Practices are compliant to applicable global federal regulations and select quality standards deemed strategic to the service offering.
• Services as Responsible Authority
• Remains current on global regulations as it relates to scope of business as a storage facility.
• Ensures business remains compliant to all applicable regulations related to storage business.

• Team Member Management 15%
• Directs daily tasks of the 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, onboards and trains new team members.

• Other As needed 5%
• Ensures budgets and schedules are developed, established and achieved.
• Supports cross business projects as assigned.
• Travel required, up to 20% of time.

Other Duties

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.

Reporting Relationships:

The Senior Director of Global Quality Assurance and Regulatory Affairs Storage Platform reports directly to the Senior Vice President/Chief Quality Officer.

All members of the Quality Assurance Team, Storage Platform, reports into this position.

Position located in Cranbury, NJ or Billerica, MA SciSafe locations

Job Requirements:

• Knowledgeable about and experience with compliance to cGMP, EUDRALEX, Good Distribution Practices (GDP) and CBER and CDER regulated Quality Management Systems
• Experience overseeing the Quality Program for biorepository operations.
• 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
• Must be able to interact with clients in a manner that is collaborative and professional.

Job Specifications:

• A minimum of a bachelor’s degree in in Biological or Chemical related curriculum with at least 10+ years experience working in Quality Assurance with a minimum of 3 years working in biorepository QA/RA.
• A minimum of five 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 and background check.

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.