Lab Quality Manager - Experic

Experic is an industry-leading contract development and manufacturing organization (CDMO) and clinical trial supply services company. Our vision is to deliver innovative and scalable solutions for every phase of a product's life cycle from clinical to commercial. We offer advanced pharmaceutical manufacturing, packaging, and labeling technologies that can accommodate a variety of dosing and packaging formats. We take pride in our precision capabilities, state-of-the-art filling equipment, advanced technologies, and Class A regulatory compliant cGMP facilities. Our main goal is to provide our clients with personalized attention and ensure the smooth and successful completion of their pharmaceutical development programs.

We aspire to develop a team culture based on trust, integrity, ethical behavior, and compliance, with a relentless focus on delivering high quality results. If you value a collaborative work environment and are energized by the opportunity to truly make a difference, come and Experience the Experic difference. We believe in fostering a fair and respectful work environment that encourages open communication and continuous improvement. At Experic, you can experience a fulfilling career, do meaningful work, and grow professionally and personally. A successful candidate will bring their unique thinking, expertise, and approach while sharing our core values.

Summary/Objective

The Lab Quality Manager is responsible for ensuring compliance with Good Manufacturing Practices (GMP) regulations and maintaining the highest quality standards in all laboratory operations. This role involves overseeing laboratory quality programs, conducting internal audits, ensuring operation adherence to regulatory guidelines, and leading continuous improvement initiatives within the laboratory. The ideal candidate will have a strong background in chemistry or biology and possess extensive experience in quality management within a GMP-compliant environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

• GMP Compliance:
  • Ensure that laboratory activities comply with GMP regulations, as well as other applicable regulatory requirements (FDA, EMA, etc.).
  • Develop, implement, and maintain GMP policies and procedures across the laboratory.
  • Oversee quality control measures to ensure the accuracy, precision, and reliability of laboratory data.
• Quality Assurance Program:
  • Lead the development, implementation, and maintenance of the laboratory Quality Program.
  • Conduct internal audits of laboratory processes to ensure compliance with GMP and identify areas for improvement.
  • Collaborate with cross-functional teams to ensure quality standards are integrated into laboratory operations.
• Training and Education:
  • Develop and conduct GMP training programs for laboratory staff, ensuring laboratory personnel understand and comply with quality standards.
  • Keep staff informed of updates to GMP regulations and industry best practices.
• Document Control and Management:
  • Oversee the creation, review, and approval of all GMP-related documents, including Standard Operating Procedures (SOPs), protocols, and test procedures.
  • Ensure proper documentation of deviations, investigations, and corrective/preventive actions (CAPAs).
• Risk Management:
  • Identify and assess quality risks related to laboratory operations and implement mitigation strategies.
  • Lead investigations into quality issues and implement corrective actions to prevent recurrence.
• Continuous Improvement:
  • Lead continuous improvement initiatives focused on enhancing laboratory quality and compliance.
  • Monitor and report key quality metrics to senior management, driving a culture of quality throughout the organization.
• External Audits and Regulatory Inspections:
  • Prepare the laboratory for audits, audit responses, and ensure timely resolution of any findings.

QUALIFICATIONS: EDUCATION and/or EXPERIENCE

Qualifications

Education:

• Bachelor's degree in Chemistry, Biology, or a related scientific field is required.

Certifications (Preferred):

• ASQ Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or equivalent certification.
• GxP compliance training and certification.

Experience:

• Minimum of 5 years of experience in quality management within a GMP compliant environment, preferably in the pharmaceutical or biotechnology industries.
• Experience in GMP quality reviews preferred
• Audit experience required
• Strong background in chemistry or biology, with a thorough understanding of laboratory operations and regulatory requirements.

OTHER SKILLS, ABILITIES OR QUALIFICATIONS

Skills and Competencies:

• In-depth knowledge of GMP regulations and their application in laboratory.
• Strong leadership and managerial skills, with experience in managing teams and driving quality initiatives.
• Excellent organizational skills with attention to detail and the ability to manage multiple projects simultaneously.
• Strong problem-solving and decision-making abilities.
• Excellent communication skills, both written and verbal, with the ability to effectively communicate quality issues to laboratory staff and senior management.
• Proficiency in quality management software and Microsoft Office Suite.

Work Environment

• This position will primarily be based in a laboratory setting, with occasional office work for documentation and meetings.
• The role requires strict adherence to safety protocols and the use of personal protective equipment (PPE) as needed.

TRAVEL

• Domestic travel will be required less than 10% of the time.

The job demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to reflect those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards. The percentage of time spent performing the various job duties is not absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.

EXPERIC is an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.