Job Title: VP of Quality

Job Code:

Department: Quality

Department Code: 4300

Reports to: Chief Executive Officer

FSLA: Exempt

General Summary:

The Vice-President/Senior Director of Quality Assurance oversees and directs the Quality Assurance & QC function responsible for driving the company’s QA & QC strategy, Quality Management Systems, and policies. The ideal candidate will be responsible to lead Quality Control & Quality Assurance activities, the Quality Management Systems (QMS), assure compliance to USA FDA GXP regulations across products and all regulatory audit and inspection activities. This position will be responsible for translating the company’s quality strategy into SOPs, tactical policies, processes, and procedures to ensure 100% compliance with meeting global regulatory standards at all times.

Essential Duties and Responsibilities:

  • Responsible for overall direction, coordination, and evaluation of the reporting departments (QA, QC, RA, and Validation) and functions
  • Lead the Quality Assurance department in all GXP functional areas (GMP, GLP, GCP, GXP document control, GXP training) as client programs transition from early phase through clinical & commercial development/manufacturing to release readiness
  • Lead the development, implementation and management of GXP quality and compliance systems and policies, including the development of QA and QC processes and procedures
  • Asses current, and where needed, develop corporate and/or other organizational polices related to GXP compliance and oversee their implementation, including quality standards and SOPs
  • Implement governance plan to ensure good communication and decision making at the appropriate levels for quality related topics
  • Provide technical assistance and direction in the area of chemistry, microbiology, and physical testing to ensure adherence to quality standards and objectives
  • Develop, implement and monitor Quality operation budget to ensure compliance with approved expense limitations. Determine cause of variance to budget and applicable corrective actions.
  • Responsible for staffing the Quality department and ensuring training of employees; planning, assigning, and measuring work; development of staff, talent assessments and succession planning
  • Ensure company is regulatory inspection ready at all times (Regulatory Agencies and Client)
  • Plan, coordinate, and direct PAI readiness for new and existing clients
  • Oversee the planning and conduct internal and external audits to ensure compliance with GCP regulatory requirements for clinical trials and GMP regulatory requirements for investigational and commercial drug manufacturing, and ensure corrective actions are implemented to resolve audit findings
  • Manage, as the primary point of contact, internal and regulatory agency inspections
  • Develop proactive approaches and provide strategic direction to implement quality standards and procedures for GXP regulatory compliance to meet company needs
  • Ensure products and processes meet all specifications and requirements before approving the release to clients
  • Develop and manage relationships with senior Quality representatives from clients, vendors, and collaborators
  • Select, provide training for, motivate and develop a highly technical staff with expertise in a wide variety of disciplines to accomplish departmental objectives
  • Keep current on changes in industry and regulatory standards for GXP requirements and advise on business impact
  • Maintain current knowledge of new regulatory developments
  • Advise Company's Executive Team and parent company on the implications and risks related to key Quality issues and important strategic decisions; keeping all posted, on a timely basis
  • Assist clients in investigations of customer complaints and submit appropriate reports (timely)
  • Identify quality improvement needs and opportunities and assure that appropriate personnel address the issues. Assure corrective actions are implemented
  • Establish the general quality policies and standards used by Company in the qualification of facilities and in the manufacturing and testing of products
  • Host regulatory and client representatives in audits and inspections
  • Lead and coordinate the efforts within the entire operation to formulate and implement corrective actions to internal and external assessments

Job Requirements:

  • Minimum of a Bachelors’ degree, ideally in a bio-chemistry, life sciences, or microbiology related field; Advanced degree will be given preference, however, extensive industry experience acceptable in lieu of advanced degree
  • At least 10 years of experience in positions of substantial management responsibility within Quality Assurance
  • Substantial experience in leading and participating in regulatory inspections and preparing staff for regulatory inspections
  • Experience with documentation systems, document review and auditing responsibilities
  • Ability to read, analyze, and interpret common scientific and technical documents; in-depth understanding of department budgets and financial statements, and legal documents
  • Ability to effectively respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community
  • Ability to effectively present information to top management, public groups, and/or boards of directors
  • Ability to apply advanced mathematical concepts and operations such as logarithms, permutations, frequency distribution, analysis of variance, determination of test reliability and validity, and sampling theory and develop these skills in staff
  • Ability to define problems, collect data, establish facts, and draw valid conclusions
  • Demonstrated ability in setting successful quality strategies and building and leading the function
  • Ability to evaluate complex situations and to render judgments where significant legal, financial, and regulatory risks exist, and when compliance guidelines are vague or not available
  • Extensive knowledge of biopharmaceutical manufacturing processes, equipment, and testing
  • Knowledge of relevant regulations, including FDA, EMEA, ICH.
  • Ability to build consensus among colleagues with an appropriate level of flexibility, while maintaining a focus on results and goal attainment
  • Strong managerial and organizational ability
  • Ability to think strategically and translate into action
  • Ability to respond effectively to the most sensitive inquiries or complaints
  • Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups, and/or boards of directors

Physical Demands:

While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Ability to travel domestically and internationally (approx. 10-15%).

Work Environment:

The noise level in the work environment is usually moderate.

Job Type
Full-Time Regular