Site Head of Quality

Summary of the position:

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.

Responsible for overseeing Quality Assurance and Quality Control operations at Guerbet Raleigh

Essential Functions & Responsibilitie

• Responsible for establishing a Quality Culture aligned with CGMPs and Guerbet Global standard
• Ensure Quality Systems are robust and continuously improve
• Responsible for ensuring that QA and QC teams (e.g., Quality Systems, Quality Operations, Microbiology) are properly staffed and trained to support compliant manufacturing operation
• 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 meeting
• 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 goal
• Ensure the site is always ready for inspections and audit
• 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
• Ensure CGMP documents are current and meet applicable regulatory agency requirements, and Guerbet Global policies
• Ensure QA and QC personnel have approved job description and that performance management procedures are followed

Department Specific/Non-Essential Functions

• Coaching and mentorship skills
• Perform other duties as assigned by management

Education, Experience, and/or Skills

Required:

• 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
• 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

Preferred:

• Experience in finance, supply chain, Operational Excellence, and HSE
• 3-5 years of experience in sterile manufacturing

Physical Requirements

• Ability to lift up to 35lbs. without assistance

Cognitive Requirements

• 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.

Working Conditions

• Occasionally work in areas where personal protective equipment will be required.
• Work in areas wherein sitting is required for extended periods, with occasional standing and walking.
• Daily and frequently work in front of a computer screen or under bright lighting conditions.
• Ability to travel to domestic and international destinations, as required by business needs.

Organizational Relationship Scope

• Reports to Director Quality Technical Operations and dotted line to Site Director.
• .Responsible for managing 5-7 direct reports
• Scope is Raleigh but expected to work with other Guerbet sites and affiliates, when required.
• Communicate with regulatory agencies when needed.

Monetary Responsibility

• Develop yearly budget for the Quality unit.