B2S Life Sciences LLC
Job Description
Job Description Description:
Principal Function:
The
Director of Quality Operations
is responsible for determining and maintaining the Quality Management System (QMS) and complying with all relevant regulations and quality standards set by the industry. This position is responsible for the quality staff and QC functions supporting laboratory operations. The individual in this role is also responsible for ensuring that all quality and regulatory requirements for good laboratory practices (GLP) are in place and that we have a robust audit process to ensure compliance.
Essential Duties and Responsibilities: Collaborating with company leadership to establish priorities and solutions to improve the overall quality at B2S Life Sciences, including the quality of the final data submitted to clients. Managing QC team for review of lab data and documents. Collaborating with company leadership to establish quality processes using deviations and Corrective and Preventive Actions (CAPAs). Ensuring the draft, finalization, and approval of company-wide standard operating procedures (SOPs). Maintain a set of quality metrics to measure quality compliance and a process for continuous quality improvement. Designing and implementing training procedures to ensure standard operating procedures (SOPs) and regulatory adherence. Setting up and maintaining the Job Functions for each employee. Hosting internal and external audits, including responding to client questionnaires, audit requests, and audit observations. Owning the process governing document control Reviewing and approving all controlled documentation, including SOPs, CVs, job descriptions, etc. Serving as back-up archivist for equipment documents and reviewed/approved quality-related documents. Assessing external vendors based on risk. Providing training for new employees and updating information for current employees, as needed. Supporting HR with onboarding of new employees. Other duties as assigned.
Supervisory Responsibilities:
The
Director of Quality Operations
supervises the entire quality staff in accordance with the company’s policies and applicable laws. Responsibilities include: Interviewing Hiring Training employees Planning, assigning, and directing work. Scheduling and approving time worked. Evaluating performance Rewarding and disciplining employees Addressing complaints and resolving problems in accordance with company policy. Organization-Related Competencies: Organizational Support Teamwork Adaptability Ethics People Skills Managing People Analytical Quality and Productivity Oral and Written Communication Problem Solving Safety and Security Requirements: Education and/or Experience: Bachelor’s degree (B.A./B.S.) from a four-year college or university in a life science field and 5-years of experience in related field; or associate degree (A.A.) in a life science field and 10-years of experience in related field and/or training; or equivalent combination of education and experience is required. Previous experience managing quality systems in the biotech industry is required. In-depth knowledge of the Good Laboratory Practices (GLP) and familiarity with Good Manufacturing Practices (GMP) (21CFR Part 11 and 58) are required. Experience auditing in a Good Laboratory Practice/Good Manufacturing Practice (GLP/GMP) environment, or document control as it relates to bioanalysis is required. Supervisory experience is preferred. Other Skills and Abilities: Computer software skills including Microsoft Office Suite, Lockbox LIMS, Salesforce, SharePoint, and Paylocity. The ability to maintain confidentiality is required. Develop positive working relationships and interact effectively with clients and colleagues. Prepare reports, Standard Operating Procedures (SOPs), and other documents. Analyze and evaluate data, make determinations. Clearly and concisely present findings in oral or electronic formats. Communicate complex ideas in a public forum. Develop good relationships with the larger business community. Problem-solve and exercise independent judgment within established protocols and guidelines. Work independently and as a team. Manage and prioritize multiple projects simultaneously. Interact professionally and constructively with clients, team members, and co-workers. The ability to be sensitive to professional ethics, gender, cultural diversities, and disabilities. The ability to travel out-of-town on company business and/or attend or speak at conferences and training sessions. Working knowledge of software validation requirements, statistical visualization software applications, and various survey tools. Working knowledge of the International Conference on Harmonization (ICH) guidelines. Physical Demands Ability to stand less than 1/3 of the time. Ability to walk less than 1/3 of the time. Ability to sit more than 2/3 of the time. Ability to talk or hear from 1/3 to 2/3 of the time. Ability to lift 20 lbs. less than 1/3 of the time. Work Environment The work environment is in an office and laboratory environment. Travel up to 5% percent of the time. Frequent use of a computer. This position requires working independently, as well as part of a team. While performing the duties of this job the noise level in the work environment is usually moderately loud and has moderate temperatures. Personal protective equipment must be worn in designated lab areas: closed-toed shoes, laboratory coat, safety goggles, and gloves. This position requires the use of all general office and lab equipment. Potential exposure to pathogens.
This position may require work beyond business hours on weekends and holidays. A valid driver’s license is required as it may be necessary to drive one’s personal vehicle on B2S Life Sciences business.
Job Description Description:
Principal Function:
The
Director of Quality Operations
is responsible for determining and maintaining the Quality Management System (QMS) and complying with all relevant regulations and quality standards set by the industry. This position is responsible for the quality staff and QC functions supporting laboratory operations. The individual in this role is also responsible for ensuring that all quality and regulatory requirements for good laboratory practices (GLP) are in place and that we have a robust audit process to ensure compliance.
Essential Duties and Responsibilities: Collaborating with company leadership to establish priorities and solutions to improve the overall quality at B2S Life Sciences, including the quality of the final data submitted to clients. Managing QC team for review of lab data and documents. Collaborating with company leadership to establish quality processes using deviations and Corrective and Preventive Actions (CAPAs). Ensuring the draft, finalization, and approval of company-wide standard operating procedures (SOPs). Maintain a set of quality metrics to measure quality compliance and a process for continuous quality improvement. Designing and implementing training procedures to ensure standard operating procedures (SOPs) and regulatory adherence. Setting up and maintaining the Job Functions for each employee. Hosting internal and external audits, including responding to client questionnaires, audit requests, and audit observations. Owning the process governing document control Reviewing and approving all controlled documentation, including SOPs, CVs, job descriptions, etc. Serving as back-up archivist for equipment documents and reviewed/approved quality-related documents. Assessing external vendors based on risk. Providing training for new employees and updating information for current employees, as needed. Supporting HR with onboarding of new employees. Other duties as assigned.
Supervisory Responsibilities:
The
Director of Quality Operations
supervises the entire quality staff in accordance with the company’s policies and applicable laws. Responsibilities include: Interviewing Hiring Training employees Planning, assigning, and directing work. Scheduling and approving time worked. Evaluating performance Rewarding and disciplining employees Addressing complaints and resolving problems in accordance with company policy. Organization-Related Competencies: Organizational Support Teamwork Adaptability Ethics People Skills Managing People Analytical Quality and Productivity Oral and Written Communication Problem Solving Safety and Security Requirements: Education and/or Experience: Bachelor’s degree (B.A./B.S.) from a four-year college or university in a life science field and 5-years of experience in related field; or associate degree (A.A.) in a life science field and 10-years of experience in related field and/or training; or equivalent combination of education and experience is required. Previous experience managing quality systems in the biotech industry is required. In-depth knowledge of the Good Laboratory Practices (GLP) and familiarity with Good Manufacturing Practices (GMP) (21CFR Part 11 and 58) are required. Experience auditing in a Good Laboratory Practice/Good Manufacturing Practice (GLP/GMP) environment, or document control as it relates to bioanalysis is required. Supervisory experience is preferred. Other Skills and Abilities: Computer software skills including Microsoft Office Suite, Lockbox LIMS, Salesforce, SharePoint, and Paylocity. The ability to maintain confidentiality is required. Develop positive working relationships and interact effectively with clients and colleagues. Prepare reports, Standard Operating Procedures (SOPs), and other documents. Analyze and evaluate data, make determinations. Clearly and concisely present findings in oral or electronic formats. Communicate complex ideas in a public forum. Develop good relationships with the larger business community. Problem-solve and exercise independent judgment within established protocols and guidelines. Work independently and as a team. Manage and prioritize multiple projects simultaneously. Interact professionally and constructively with clients, team members, and co-workers. The ability to be sensitive to professional ethics, gender, cultural diversities, and disabilities. The ability to travel out-of-town on company business and/or attend or speak at conferences and training sessions. Working knowledge of software validation requirements, statistical visualization software applications, and various survey tools. Working knowledge of the International Conference on Harmonization (ICH) guidelines. Physical Demands Ability to stand less than 1/3 of the time. Ability to walk less than 1/3 of the time. Ability to sit more than 2/3 of the time. Ability to talk or hear from 1/3 to 2/3 of the time. Ability to lift 20 lbs. less than 1/3 of the time. Work Environment The work environment is in an office and laboratory environment. Travel up to 5% percent of the time. Frequent use of a computer. This position requires working independently, as well as part of a team. While performing the duties of this job the noise level in the work environment is usually moderately loud and has moderate temperatures. Personal protective equipment must be worn in designated lab areas: closed-toed shoes, laboratory coat, safety goggles, and gloves. This position requires the use of all general office and lab equipment. Potential exposure to pathogens.
This position may require work beyond business hours on weekends and holidays. A valid driver’s license is required as it may be necessary to drive one’s personal vehicle on B2S Life Sciences business.