Company Overview:

For more than 20 years VaLogic has been a reliable and trusted partner for GxP compliance. We offer a wide range of services. Our specialization in pharmaceuticals, biotechnology and life science ensures that we guarantee unwavering compliance, operational efficiency, and excellence. Our mission, “To support those on the quest for the cure.”

Job Title: Director of Quality Assurance

FLSA Status: Salaried/Exempted

Job purpose

The Director, Quality Assurance will lead the quality function by supporting and providing oversight of quality activities, establish and manage quality systems, and ensure GXP compliance. The candidate will be hands-on and actively involved in executing QA strategy, collaborate cross-functionally with various departments within the organization, and ensure effective communication and constructive working relationships with colleagues and business partners.

Duties and Responsibilities

Below are the primary job duties and responsibilities. This is not an exhaustive list of responsibilities:

• Overall responsible for the management of the Quality Management System, including and not limited to, CAPA, change control, investigations, complaints, audits, all issues cGMP and regulatory
• Ensure SOP’s (Standard Operating Procedures) are in compliance with GxP, ISO and pertinent regulatory bodies
• Oversees and ensure area policies are consistent with company policies and manages the application and administration of such policies in quality assurance operations in conformity with cGMP’s
• Communicates with all service departments, and leadership regarding Quality Assurance
• Approve and review reports, methods, validations and protocols in all service lines, safety and regulatory functions as necessary
• Manage Change Control
• Write and review SOP’s
• Directs and coordinates the activities of QA employees
• Oversees routine internal audits of quality management systems
• Assist and manage audits conducted by regulatory agencies, clients, and consultants
• Perform supplier quality audits as needed
• Assist in writing and preparing responses to the audit findings by clients and regulatory agencies
• Communicate compliance issues to the leadership as they arise.
• Review and approve standard operating procedures, instrument calibration/validation/qualification protocols and reports, validation protocols and reports, study protocols and reports, investigations, extensions, and Corrective and Preventive Actions (CAPA).
• Manage investigations (non-conformance, deviations, Out of Specifications) program. Ensure timely completion of investigations.
• Ensure adequacy of investigations with respect to root cause/s analysis, and CAPA assessment.
• Conduct and document training on SOPs, and cGMP topics as deemed necessary.

• Qualifications and Skills

• Education and Experience
  • Professional degree (BA, BS, MS) in a biotech- or pharmaceutical-relevant major such as Microbiology, Biology, Biochemistry, Chemistry, or Engineering.
  • At least 7-10 years of relevant industrial experience with increasing levels of responsibility in areas such as drug development and clinical manufacturing, Validation, Quality Control, Quality Assurance, and Manufacturing. Demonstrated expertise with cGMP requirements and current industry practices are required.
  • Understanding of global regulations, FDA Guidance for Industry. Points to Consider, ICH Guidelines and Industry Best Practices
• Skills and Abilities
  • Excellent organizational, interpersonal skills, and communication (written and verbal) skills.
  • Demonstrated leadership skills, able to lead a team as well as work productively as an individual contributor.
  • The ability to exercise independent administrative judgment.
  • The ability to handle diverse tasks in an active office.
  • Working knowledge and experience in MS Word, MS Excel, MS PowerPoint preferred.
• Direct reports
  • Responsible for all employment processes, development and performance of departmental staff
• Conclusion

This job description is intended to convey information essential to understanding the scope of the job and the general nature and level of work performed by job holders within this job. But this job description is not intended to be an exhaustive list of qualifications, skills, efforts, duties, responsibilities or working conditions associated with the position.

EEO Statement:

VaLogic Bio, LLC is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

VaLogic Bio, LLC (VaLogic) does not accept unsolicited resumes from search firms or any other third parties. Any unsolicited resume sent to VaLogic will be considered VaLogic property, and VaLogic will not pay a fee should it hire the subject of any unsolicited resume.