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Quality Manager - Pharmaceutical GMP Laboratory PlumGXP Allentown, PA Job Details Full-time $87,000 - $96,000 a year 7 hours ago Benefits Health savings account Health insurance Dental insurance 401(k) Paid time off Parental leave Employee assistance program Vision insurance 401(k) matching Life insurance Qualifications Data integrity assurance Biology Regulatory inspections Teamwork Investigations regulatory compliance Document control experience within pharmaceutical industry ISO standards Pharmaceutical regulatory compliance Microbiology testing Technical writing experience within manufacturing Production deviation management Compliance audits & assessments Corrective and preventive actions (CAPA)

FDA 21 CFR

Part 11 Internal investigations Laboratory quality control records management Bachelor's degree Attention to detail Pharmaceutical company experience Data quality monitoring Compliance documentation Organizational skills Internal compliance assessments Biomedical regulatory compliance Microbiological analysis GMP for research safety and compliance Audit support Pharmaceutical manufacturing facility experience Laboratory compliance and regulatory documentation Full Job Description About PlumGXP PlumGXP is a growing pharmaceutical contract testing laboratory supporting pharmaceutical, biotechnology, medical device, compounding, and life sciences organizations. Our laboratory is being built around strong scientific expertise, modern technology, responsive client service, and a practical, risk-based quality culture. We are looking for an experienced Quality Manager who wants the opportunity to help build, implement, and continuously improve the quality systems of a growing GMP laboratory. This is a hands-on role for someone who understands that quality is more than documentation—it is an integral part of laboratory operations, data integrity, scientific decision-making, and client confidence. Position Summary The Quality Manager will lead and maintain PlumGXP's Quality Management System and provide independent quality oversight of laboratory operations. The successful candidate must have direct experience in pharmaceutical GxP environments, ISO/IEC 17025, and microbiology laboratory testing . This position will work closely with laboratory leadership and technical personnel to ensure laboratory activities are scientifically sound, properly documented, compliant, inspection-ready, and aligned with applicable regulatory and accreditation requirements. Because PlumGXP is a growing organization, this role offers significant opportunity to influence how our quality systems, processes, electronic systems, and laboratory culture are developed. Key Responsibilities Lead, maintain, and continuously improve the PlumGXP Quality Management System. Ensure compliance with applicable GMP/GxP requirements, ISO/IEC 17025:2017, USP requirements, FDA expectations, and internal quality standards . Provide Quality oversight of pharmaceutical microbiology laboratory operations and testing. Review and approve SOPs, policies, controlled forms, specifications, protocols, reports, and other GMP documentation. Manage the document control and records management programs.

Lead or oversee:

Deviations and investigations CAPA Change control Out-of-specification and atypical result investigations Laboratory incidents Risk assessments Quality events Effectiveness checks Support method qualification, verification, validation, and transfer activities. Provide Quality oversight of equipment qualification, calibration, maintenance, and computerized laboratory systems. Support environmental monitoring, water testing, microbial testing, sterility, endotoxin, microbial identification, and other microbiology-related laboratory programs. Establish and maintain supplier qualification and vendor management programs. Perform and coordinate internal audits and management reviews. Host and support client audits, regulatory inspections, supplier questionnaires, and accreditation assessments. Maintain laboratory inspection readiness. Support employee training, qualification, competency assessments, and continuing training programs. Monitor quality metrics and identify opportunities for continuous improvement. Review laboratory records and data for completeness, accuracy, traceability, and data integrity. Support implementation and administration of electronic quality systems. Partner with laboratory management while maintaining appropriate Quality independence and authority. Promote a culture in which compliance, scientific integrity, and practical problem-solving are shared responsibilities across the organization. Required Qualifications Candidates must have demonstrated experience in all of the following areas: Pharmaceutical or biopharmaceutical Quality experience. Strong working knowledge of GMP/GxP requirements . Experience working within an

ISO/IEC 17025

Quality Management System . Direct experience supporting or overseeing pharmaceutical microbiology laboratory testing . Experience with deviations, investigations, CAPA, change control, document control, and training systems. Experience reviewing laboratory records, protocols, reports, and controlled documentation. Knowledge of laboratory data integrity principles. Experience supporting audits, inspections, or regulatory/accreditation assessments. Ability to interpret regulatory and compendial requirements and translate them into practical laboratory processes. Strong technical writing, communication, organizational, and problem-solving skills. Preferred Qualifications Additional experience in one or more of the following areas is highly desirable: Computer System Validation ( CSV ). 21 CFR Part 11 compliance. Electronic records and electronic signatures. Electronic Quality Management Systems ( eQMS ). Data integrity assessments and computerized-system risk assessments. Equipment qualification and validation. Method validation, verification, or transfer. FDA-regulated contract laboratory environments. Experience helping establish or expand a Quality Management System in a new or growing laboratory. Education and Experience Bachelor's degree in microbiology, biology, chemistry, pharmaceutical sciences, quality, or a related scientific discipline required. Advanced degree or professional quality certification is a plus. Multiple years of progressive Quality experience within pharmaceutical, biotechnology, or other regulated life sciences environments. Prior Quality leadership or supervisory experience strongly preferred. The Person We Are Looking For The right candidate will be comfortable operating in both strategic and hands-on capacities. PlumGXP is building a modern laboratory, and we are looking for someone who enjoys developing effective systems—not simply maintaining legacy processes. You should be able to work collaboratively with scientists and leadership while also being willing to challenge a process, decision, or record when Quality requirements are not being met.

We value people who are:

Scientifically minded. Detail-oriented without losing sight of operational practicality. Comfortable making risk-based decisions. Collaborative and approachable. Confident interacting with clients, auditors, and regulators. Able to distinguish between regulatory requirements, industry convention, and unnecessary bureaucracy. Excited about helping build a laboratory and Quality organization from the ground up. Why PlumGXP This is an opportunity to play a meaningful role in the development of a growing pharmaceutical testing laboratory. Rather than inheriting a mature Quality system and simply maintaining it, the Quality Manager will have the opportunity to help shape PlumGXP's systems, standards, technology, and quality culture as the organization expands. PlumGXP is committed to building a laboratory where strong science, quality, technology, employee development, and exceptional client service work together. If you have strong pharmaceutical

GMP, ISO

17025, and microbiology Quality experience and are interested in helping build the next generation of contract laboratory operations, we would like to hear from you.

Pay:

$87,000.00 - $96,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Health insurance Health savings account Life insurance Paid time off Parental leave Vision insurance

Work Location:

In person