Director, Quality Assurance - CARR Biosystems

About Us:

As a member of the Barry-Wehmiller family of companies, CARR Centritech has been an industry leader in centrifugation for more than three decades. Today, CARR Biosystems continues that pioneering legacy by delivering high-performance, fully-scalable bioprocessing solutions to accelerate process development. Our mission is to advance life-saving and life-enhancing solutions worldwide by supplying the best bioprocessing equipment on the market. In the process, we empower scientists and engineers to produce vital biologics in emerging and established markets, including cell and gene therapy, vaccine development, microbial fermentation and cellular agriculture. For more, visit carrbiosystems.com.

 

Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.

 

Job Description:

We have an exciting opportunity for a dynamic and detail-oriented Quality Assurance professional with experience in the Biotech or Life Sciences industry. This position will be focused on our rapidly-expanding Life Sciences business unit which includes the first single-use centrifuge system for bioprocessing.  The position requires interaction throughout the organization and the Director of Quality Assurance will be the quality assurance liaison with Senior Leadership. The Director of Quality Assurance will implement and improve our Quality Management System (QMS) in compliance with applicable regulations including but not limited to 21 CFR Part 210-211 as it applies to a supplier of equipment and single use systems (SUS) to the biopharmaceutical industry. Integration of the quality system with ISO 9001 is also required.  The successful candidate will provide clear direction and leadership to the quality department and foster an environment of continuous improvement and “first time right”.  

Job Details

• Reports to VP, Operations
• Full time role
• Located in Clearwater Florida

Specific Job Roles Include:

• Implement a quality strategy that aligns closely with the Carr Centrifuge business strategy.
• Participate in the development and/or enhancement of Carr Centritech strategy and QA business processes, procedures, and best practices.
• Represent Quality at strategic non-project team and at strategic discussions.
• Integration of a QMS that can satisfy both ISO 9001 and the appropriate cGMP requirements as they apply the SUS manufacturing. 
• Create and sustain a dynamic QMS that is continually being improved through cooperation with other departments including engineering, R&D and Manufacturing. 
• Implement customer feedback program.
• Implement supplier/vendor quality program and lead vendor audits.
• Choose and implement an electronic quality management system that will support rapid growth plans. 
• Assure appropriateness and completeness of required documentation for manufactured products.
• Manage quality risk assessment and inspection readiness program to prepare for customer or regulatory audits. 

• Actively participate in special assignments on various project teams and work streams.

• Ensure adequate and timely escalation of incidents/issues within QA. Lead formal investigations of issues as they arise, ensuring timely escalation to line management if critical observations are not resolved.
• Facilitate the implementation of the quality strategy in close alignment with the Carr Centrifuge business strategy. Monitor and track implementation and break-down of the Quality Manual into an annual Quality Plan, including the quality risk assessments and inspection readiness components for the designated programs.

• Interact with senior leadership to ensure Quality is consistently and proactively represented at program level to ensure high data quality and proactive detection and resolution of issues.

• Ensure appropriate review of all quality and compliance related topics.
• Effectively communicate with leadership on topics/issues impacting the quality and compliance of the Carr Centritech product line.
• Ensure adequate and timely escalation of incidents/issues within QA. Lead formal investigations of issues as they arise, ensuring timely escalation to line management if critical observations are not resolved in due course.
• Recognizes risk and proposes contingency plans. Directs investigation of manufactured product to assure appropriateness and completeness of required documentation.
• Leads quality group to collaboratively address compliance concerns and/or needs.  Directs QA colleagues to ensure that tasks are completed to meet client needs in the agreed upon time frame.  
• Ensure continued submission and inspection readiness for the Carr Centritech team and related submissions. Facilitate respective regulatory inspection preparation, management, and follow-up. Support local inspections with adequate systems and process support.
• Provides leadership to and manages regulatory consultants (both team members and contractors) to provide services to clients.
• Directs Quality Assurance Operations functions associated with Carr Centritech product line.

Education:

• Bachelor’s Degree in Life Sciences or Biotechnology
• Demonstrated leadership including five years management experience.
• Additional training or certification such the CMQ/OE offered by the American Society of Quality (ASQ) is preferred. 
• Sound judgment, analytical, problem-solving and decision-making skills.
• Ability to handle multiple assignments and changing priorities along with fluctuations in workload.  
• Demonstrated planning, project management, negotiation, facilitation and presentation skills.
• Ability to work both independently and collaboratively in a team structure.  Uses a team-oriented approach to project management and problem resolution. Holds self and others accountable in achieving collective goals.
• Excellent verbal and written communication skills, including the ability to generate SOPs and regulatory documents.  
• Proficiency with Microsoft Project, Word, Excel and PowerPoint required.

 

At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job.  If your experience is close to what you see listed here, please still consider applying.  We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions.  Please let us know if you require reasonable accommodations during the interview process. ​

Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.

 

Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

 

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