GDP QA Manager - Distribution

Job Description

Title: Quality Assurance Manager, Distribution

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

Duration: 1+ year contract

Pay rate: $70-$75/hr

Job Location: Boston, MA, hybrid

Schedule: M-F, standard business hours

Job#: bh17708

POSITION SUMMARY:

The Quality Manager ensures medicines are distributed globally in compliance with GDP and GMP requirements, overseeing Third Party Logistics (3PL) providers and supporting key stakeholders.

KEY ACCOUNTABILITIES:

Oversee 3PL providers:

Prepare and maintain Quality Agreements.

Review deviations, CAPAs, and changes.

Maintain KPIs and resolve compliance/customer issues.

Escalate critical issues.

Stay updated on GDP/logistics regulations and guide QMS maintenance.

Support strategic global logistics projects.

Collaborate with internal and external stakeholders.

KEY RESPONSIBILITIES:

Maintain the QMS and ensure compliance with distribution licenses.

Support product recalls, mock recalls, and on-market activities.

Approve Change Controls and manage risk assessments for GDP/GMP actions.

Participate in GDP Management Reviews and recommend mitigation strategies.

Support quality-related aspects of expansion projects (e.g., QMS development, license applications, audits).

Prepare for and host regulatory inspections; manage post-inspection follow-ups.

Manage event investigations, CAPAs, and effectiveness checks.

Ensure proper handling of product complaints, supplier approvals, and subcontracting activities.

Conduct self-inspections and implement corrective actions.

Decide on the final disposition of returned/rejected medicines and ensure adherence to legal requirements.

Create, review, and approve SOPs and quality documents.

MINIMUM QUALIFICATIONS:

Bachelor’s degree in a scientific/allied health field (or equivalent) with 5+ years of relevant experience.

PREFERRED QUALIFICATIONS:

Expertise in GDP/GMP with 5+ years in a Quality role.

Strong understanding of compliance and operational quality.

Influential communication and interpersonal skills.

Auditing experience; qualifications are an advantage.

Proficiency in Microsoft Office.

Fluency in English.Company Description

Connexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.

Full-time

Hybrid remote