Site Head of Quality

About the role

The Site Head of Quality has the primary responsibility for overseeing the Quality Operations for commercial manufacturing and packaging for sterile, commercial dosage products. This position will focus on the development and continuous improvement of systems to ensure compliance to CGMP’s that meet company goals and the expectations of the markets in which Guerbet commercializes products. The Site Head of Quality will ensure a culture of compliance throughout the manufacturing, testing, packaging, and warehouse areas.

Responsibilities

• Establish a Quality Culture aligned with CGMPs and Guerbet Global standards.
• Ensure Quality Systems are robust and continuously improved.
• Ensure Quality Assurance and Quality Control operations are properly staffed and trained to support compliant manufacturing operations.
• Ensure quality system’s performance indicators (leading and lagging) are identified, monitored, and communicated to site leadership and Corporate Quality to ensure actions (corrective and preventive) are implemented.
• Partner with the Site Lead Team to drive the mission and vision for the site.
• Serve as the site liaison for Corporate Quality matters, actively engaging in cross-site quality forums and global QA leadership meetings.
• Participate in corporate quality improvement projects and strategic programs, sharing best practices, and lessons learned to enhance group-wide quality performance.
• Establish clear quality goals and objectives that align with organizational goals.
• Ensure the site is always ready for inspections and audits.
• Lead, coach, and mentor the Quality organization.
• Model the behavior of “doing the right thing, even when no one is looking” on issues of quality.
• Point person for regulatory agency inspections, communications, and any action because of these.
• Identify and escalate critical quality issues proactively, ensuring timely communication and resolution of escalated matters with Corporate QA.
• Ensure CGMP documents are current and meet applicable regulatory agency requirements, and Guerbet Global policies.
• Ensure QA and QC personnel have approved job descriptions and that performance management procedures are followed.

Requirements

Department Specific/Non-Essential Functions: - Coaching and mentorship skills. - Perform other duties as assigned by management.

Qualifications

• Bachelor or Master (preferred) in biology, chemistry, microbiology, engineering with 12-15 years of progressive leadership experience in sterile pharmaceutical manufacturing.
• Minimum of 7 years in QA or QC leadership role, preferably in both.
• Strong knowledge of regulatory authority requirements (US FDA, ANVISA, MFDS, EMA).
• Expert in CGMP’s with a proven track record for providing practical and effective solutions to address issues.
• Experience in direct interaction with FDA personnel during inspections.
• Excellent written and verbal communication skills.
• A highly motivated leader that works transversally to achieve results.
• Able to work under pressure and make data-driven decisions.
• Able to teach, guide, and influence others while inclusive and respectful.

Skills

• Has strong attention to detail and organizational skill.
• Committed and engaged in making high-quality products and expects the same from others.
• Interpersonal skills to develop and mentor a department and interact with other professionals and management in the organization.
• Problem Solving - Identify problems in a timely manner; conduct analyses to identify root causes; lead fact-based group problem solving situations.
• Technical Skills - Seek training and development opportunities; strive to continuously build knowledge and skills; share expertise with others.
• Interpersonal Skills - Focus on solving personnel conflicts; maintain confidentiality; active listener; keep emotions under control; open to others' ideas.
• Oral Communication - Speak clearly and persuasively in positive or negative situations; listen and seek clarification; respond well to questions; demonstrate group presentation skills; lead and participate in meetings.
• Written Communication - Write clearly and concisely; edit work for correct spelling and proper grammar; present numerical data effectively; able to read and interpret written information.
• Teamwork - Balance team and individual responsibilities; exhibit objectivity and openness to others' views; give and welcome feedback; contribute to building a positive team environment; put success of team above own interests; able to build morale and group commitments to goals and objectives; support everyone's efforts to succeed.
• Change Management - Develop effective implementation plans; communicate changes effectively; build commitment and overcomes resistance; prepare and support those affected by change; monitor transition and evaluate results.
• Leadership - Inspire and motivate others to achieve departmental and site goals, as well as personal development goals; effectively influences actions and opinions of others; accept feedback from others; give appropriate recognition to others.

Benefits

• 4 weeks of PTO
• Insurance benefits start date of hire
• Competitive 4% 401K match + 2% profit sharing contribution
• Tuition reimbursement program for ongoing education
• Paid time off for select volunteer opportunities

Pay

• Competitive salary commensurate with experience

Schedule

• Full-time

Equal Employment Opportunity

Guerbet is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant based on race, color, religion, national origin, sex, age, disability, veteran or military status, genetic information, pregnancy or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identity, and maintain employment statistics on applicants.

Why Guerbet?

• 4 weeks of PTO
• Insurance benefits start date of hire
• Competitive 4% 401K match + 2% profit sharing contribution
• Tuition reimbursement program for ongoing education
• Paid time off for select volunteer opportunities