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MBX Biosciences, Inc. · 2 days ago

Associate Director, Quality Assurance (GCP/ GCLP)

Greater Boston

Full-time

Onsite

Lead/Staff, Director/Executive

10+ years exp

MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing novel precision peptide therapies. The Associate Director of Quality Assurance will ensure compliance with Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP), leading audits and assessing compliance risks across clinical and nonclinical programs.

BiotechnologyHealth CareTherapeutics

Responsibilities

Plan and lead GCP and GCLP audits (international and domestic), including clinical investigator site, contract clinical laboratories, and CROs to determine compliance status and identify compliance risks

Assess GCP and GCLP compliance risk areas (internal and external) and develop and implement risk mitigation measures

Assist and provide guidance for regulatory inspection readiness activities

Ensure compliance with company's procedures and regulatory requirements

Conduct QA reviews of project-related Clinical Operations/Development essential documents (e.g. protocols, amendments, case report forms, tables and listings, informed consents, investigator brochures, and Clinical Study Reports)

Review and provide input into non-clinical documentation (e.g. protocols, study reports)

Facilitate GCP/GCLP/GLP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies

Participate in the evaluation and selection of CROs and other clinical and nonclinical service providers

Provide guidance, interpretation and information on GCP and GCLP regulations, standards and quality systems to MBX functional areas

Develop and implement standards, policies and procedures for GCP/GCLP/GLP regulatory compliance

Develop and measure quality metrics to drive consistent quality standards relating to GCP, GCLP and GLP activities

Other responsibilities as assigned

Qualification

GCP complianceGCLP complianceQuality Systems experienceHealth Authority inspectionsAnalytic skillsAuditing experienceRegulatory requirements knowledgeCommunication skillsLeadership skillsTeamwork skills

Required

Bachelor's degree with minimal 10 years' experience in Biotech or Pharma and 5+ years' experience in Quality Systems related to GCP, GCLP and GLP

Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement

Firsthand experience with Health Authority inspections

Extensive experience auditing clinical CRO's, clinical/investigator sites

Understanding and application of domestic and international regulatory requirements

Outstanding communication skills (interpersonal, verbal and written)

Proven track record of industry success

Strong leadership and management skills

Excellent teamwork and collaboration skills

Excitement about the vision and mission of MBX