Site Head of Quality
- Provide leadership to the Site Quality organization to ensure that teamwork, high morale and innovation are fundamental components of a world-class team
- Develop and execute the Walkersville Quality strategy commensurate with the overall plan for the company. Ensure alignment with customer needs and linkage with the overall Quality and business strategies.
- Implement continuous improvement initiatives to drive Quality programs and ensure maximum productivity. Ensure systems are world-class and meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability.
- Develop, implement and monitor Quality programs, policies and procedures to ensure compliance with GxP standards, ISO standards, corporate policies, FDA and other regulatory body regulations and guidelines.
- Serve as the point person with industry partners regarding product quality matters, customer satisfaction levels and regulatory authority interaction. Oversee all partner and regulatory authority audits and inspections and corrective action programs in response thereto
- Evaluate all current Quality systems and processes and recommend and implement appropriate enhancements to ensure the achievement of Lonza's long-term objectives
- Create active training and development plans for Quality staff with the objective of driving the overall competence and professionalism of the Walkersville Quality functions.
- Establish and maintain a positive working relationship with customers, the FDA and other regulatory authorities. Represent the Lonza on quality and cGxP compliance issues that are specific to Walkersville
- Serve as the company Quality expert, providing solid, well-informed, actionable Quality support to Walkersville Operations, R&T, and other functions as requested.
- Perform other duties as assigned.
- Bachelor`s Degree in a Life Sciences, engineering or Quality Management or related science discipline
- Substantial direct job related experience in GMP facility manufacturing products regulated by Center for Biologics Evaluation and Research ( CBER), Center for Drug Evaluation and Research ( CDER), or Center for Devices and Radiological Health ( CDRH) with significant experience in Quality Management
- Working knowledge of:
- Aseptic practices and clean room operations
- Statistical and auditing techniques
- Environmental control procedures/equipment
- Expert knowledge of GxP, ISO Standards, FDA regulatory requirements applicable to FDA regulated products
- Regulatory Knowledge CBER, CDER, CDRH
- Strong knowledge of current industry trends and has the ability to use the latest technologies.
- Computer software skills, organization, record keeping and planning skills, budget preparation, training skills, multiple projects, time management, facilitation skills
- Assure pragmatic problem solving is carried out with a strong sense of purpose and urgency and notify/make recommendations to Management regarding serious compliance or quality issues. Routinely report on quality and compliance issues
- Demonstrated leader in the field with sustained performance and accomplishments. Ability and experience in turning around and remediating compliance challenges. Ability to plan and budget at a senior level.
- Diplomacy, negotiation skills, written and oral communication, team building skills, independent work skills, strong work ethic, coaching, delegating skills