PHARMA & BIOTECH QUALITY ASSURANCE CONSULTANTS

WE'RE HIRING | PHARMACEUTICAL & BIOTECH QUALITY ASSURANCE CONSULTANTS

Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding.

Cascades Consulting LLC is seeking experienced Quality Assurance professionals for two exciting consulting opportunities supporting a biotechnology client. We are looking for accomplished professionals who bring deep industry expertise, work independently, and thrive in collaborative, fast-paced biotech environments. Both opportunities offer remote, part-time consulting arrangements with flexible hours and an anticipated 6 to 12-month engagement, renewable.

POSITION 1: QUALITY RELEASE MANAGER (GMP)

Job ID: CC_QRM_GMP_East,

Hourly Rate: $105–$130/hour – depends on experience

Location: Remote

Engagement: Part-time | Up to 15 hours/week | 6 months, renewable

Key Responsibilities:

• Review executed manufacturing batch records and support batch disposition recommendations.
• Evaluate deviations, investigations, CAPAs, and manufacturing documentation for GMP compliance.
• Review pharmaceutical product complaints, investigations, and quality trends.
• Identify and escalate product quality, compliance, and potential regulatory concerns.

Ideal Candidate:

• 8+ years of pharmaceutical or biotechnology Quality Assurance experience.
• Strong GMP background, including batch record review, disposition support, and product complaint investigations.
• Working knowledge of FDA 21 CFR Parts 210/211, ICH Q7/Q10, EU GMP, and data integrity requirements.
• Experience overseeing contract manufacturing organizations (CMOs).
• Experience with biologics, oncology products, or Veeva Vault preferred.

POSITION 2: GCP & VENDOR QUALITY CONSULTANT

Job ID: CC_GCP_VENDOR_East

Hourly Rate: $110–$145/hour

Location: Remote | Occasional travel for audits

Engagement: Part-time | Initially 10-15 hours/week, but hours will increase as more activities come online | 6 months, renewable

Potential: Opportunity for transition to full-time permanent employment with the client.

Key Responsibilities:

• Lead vendor qualification and quality oversight of CROs, laboratories, and clinical service providers.
• Plan and conduct GCP audits of vendors, investigator sites, and Trial Master Files.
• Develop and review vendor quality agreements.
• Track audit findings, corrective actions, vendor performance, and compliance risks.
• Support clinical trial inspection readiness and TMF quality activities.

Ideal Candidate:

• 8+ years of pharmaceutical or biotechnology Quality Assurance experience, including GCP auditing and vendor oversight.
• Strong knowledge of ICH E6, applicable FDA regulations, EU clinical trial requirements, and TMF standards.
• Experience conducting CRO, vendor, and investigator-site audits.
• Experience supporting regulatory inspections and working within outsourced clinical development models.
• Oncology/hematology experience, Veeva Vault expertise, or professional auditor certification preferred.

HOW TO APPLY

Interested and qualified professionals are invited to submit their resumes and cover letters to:

IMPORTANT: Please include the Job ID in the subject line of your email so we can route your application appropriately.

Email Subject: Application – [JOB ID] – [YOUR NAME]

Candidates should have the ability to provide consulting services through an established business entity (LLC or corporation).

Application Review & Selection Process

We appreciate your interest in opportunities with Cascades Consulting. To ensure alignment with our client's needs, applicants should carefully review the minimum qualifications before applying. Candidates must meet the position's stated minimum requirements to be considered.

All applications will be reviewed against the position's qualifications and client requirements. Due to the anticipated volume of applications, only candidates selected for further consideration will be contacted. We sincerely appreciate the time and interest of everyone who applies.

We welcome referrals! If you know an experienced GMP or GCP Quality Assurance professional who may be interested, please share this opportunity with your network.

Cascades Consulting LLC

Connecting Expertise with Opportunity. xhyhwjd

Cascades Consulting LLC is committed to fair and equitable consideration of qualified candidates based on job-related qualifications, experience, and the requirements of each engagement.

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