[Hiring] Director, Global Supplier Quality & Compliance @Curia

Role Description

The Director, Global Supplier Quality & Compliance, is responsible for providing cross-functional leadership to ensure the success of the Global Supplier Quality & Compliance program. Responsibilities include:

• Ensuring success at the sites’ supplier quality program.
• Coordinating and performing global on-site supplier audit program.
• Ensuring quality and regulatory compliance standards at global GMP sites.
• Driving inspection gap assessment and risk heatmap assessment for GMP facilities within Curia network.
• Coordinating and providing oversight for compliance harmonization and continual improvement initiatives at global GMP sites.
• Leading the Center of Excellence (COE) team.
• Administering the supplier qualification process.
• Performing supplier qualification audits.
• Administering the Supplier Qualification Module within TrackWise Digital.

Qualifications

• Bachelor’s Degree in bioscience field or related study.
• Minimum of 8 years working in site Quality Operational leadership roles with QA, RA, or Compliance experience in pharmaceutical industry at US FDA regulated facilities.
• Experience must be with drugs, devices, and biologics.
• Broad knowledge of US and international cGMP regulations (e.g., 21 CFR 11, 210, 211, 820, EU GMP, ICH Q7).

Requirements

• Knowledge of CFR and state guidelines as they apply to controlled substance activities.
• Knowledge and practical application of state and federal regulatory as related to controlled substances.
• Knowledge of pharmaceutical manufacturing and service-provider compliance processes.
• US FDA/EU inspection experience (participating or leading); auditing experience is preferred.
• Experience with CAPA creation, execution, and effectiveness checks.
• Prior supervisory experience in a pharmaceutical, CRO/CDMO environment.
• Excellent communication and organizational skills, as well as negotiation, influencing, and collaboration skills.
• Proficient in building consensus, negotiating, and escalating issues.
• Good understanding of the importance and use of quality metrics.

Benefits

• Generous benefit options (eligible first day of employment).
• Paid training, vacation, and holidays (vacation accrual begins on first day of employment).
• Career advancement opportunities.
• Education reimbursement.
• 401K program with matching contributions.
• Learning platform.
• And more!

Supervisory Responsibilities

This role is responsible for leading and supporting a team, overseeing day-to-day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures. Responsibilities include:

• Fostering a positive work environment.
• Providing guidance and support to team members.
• Evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives.

Other Qualifications

• Must pass a background check.
• Must pass a drug screen.
• May be required to pass Occupational Health Screening.

Pay range: $158,000-$197,600/year. Education, experience, location, and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All interested applicants must apply online. Curia is an Equal Opportunity Employer.