Operations Quality Manager

Organization
Ancera, Inc.
Job Location
Branford, CT 06405
Job Description

Job Description

Quality Manager works closely with subject matter experts to facilitate the development and rapid adoption of value-added changes and processes, ensuring implementation is compliant with regulations, procedures, and policies.

Position Summary:

He/She will provide leadership, guidance and direction to R&D, Biology, and other staff members consistent with cGMP and company corporate quality governance. He/She will ensure that the staff has a full understanding of company processes and procedures. Finally, provide input into the department budget when appropriate and responsible for ensuring changes to manufacturing processes are controlled.

This position will interact closely with the Engineering, Manufacturing, and Applications/Sales teams to define the requirements for the quality system. The job of the quality manager is to oversee the development, implementation, operation and certification of a company‐wide quality management system (QMS) to ISO 9001 and beyond.

Key Responsibilities:

  • Lead supplier development strategy, designing the metrics for the function and supplier performance
  • Carry out supplier validation audits, with supplier support and supplier advanced product quality planning (APQP).
  • Work with Engineering (Design and Manufacturing Engineers) team to define process parameters and criteria to ensure supplier process capability is effective to meet product and process requirements
  • Support new product launches to ensure suppliers are capable of delivering to the required quality standards
  • Manage the root cause analysis and corrective actions process of supplier quality issues
  • Perform on-site supplier visits for root cause analysis and verification of corrective actions of supplier quality issues
  • Where appropriate work with the supplier directly, create corrective action plans to address process failures
  • Manage customer PPM (Parts per Million), supplier PPM, supplier problem solving on time, cost recovery and supplier warranty indicators
  • Work with management to define the quality policies and objectives
  • Work within company to define the quality processes, their interactions, and ownership responsibilities
  • Develop and maintain the quality documents and records
  • Assist with the specification, implementation and support of required infrastructure and systems, Document control systems, Product data management systems, Interface to ERP and other systems
  • He or she will be familiar with, and strive to implement, ‘Lean’ principles and methodologies.
  • Strong project management skills and experience
  • Direct involvement in day to day operations – including FMEA facilitation, Cross Functional Change Management Meetings, department streamlining/improvements, site procedure education
  • Motivate and inspire a quality compliance culture across the organization
  • Build effective and sustainable cross functional relationships
  • Drive an environment of teamwork and open communication
  • Establish key performance indicators for department
  • Accountable for project completions and achievement of such goals
  • Building collaborative cross-functional relationships
Requirements

Required Education and Experience:

  • Bachelor’s degree or equivalent and 8+ years of experience in a biotech, pharmaceutical, or similarly regulated industry
  • 5+ years of leadership experience directly related to Quality Management
  • A strong understanding of regulatory requirements affecting Biologics and Medical Devices
  • Proven Risk Management/FMEA experience/knowledge
How to Apply
About Our Organization

About Ancera, Inc.

Ancera, Inc., the leader in microbial risk assessment, is positioned to play a critical role in planning and monitoring a hierarchy of control measures that provide companies with deeper clarity and actionable outcomes in food production. The company’s Piper platform was developed to provide near real-time identification of contamination and quantification of microbial load across all points in the food production process, from farm to consumer.

Branford, CT-based Ancera was founded in 2012 and is built on the MagDrive technology developed at Yale University. It enables interactive biology through integrated label-free sorting, microscopy, enumeration, assaying and recovery of microbial and non-microbial cells directly from complex samples. The company has raised $12.3 million in venture financing from leading investors including Glass Capital, PSSI and Metabiota.


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