Lonza America Inc

Quality Site Head

Lonza America Inc$130K — $180K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 5-7 years of experience in quality assurance and quality control within GMP environments
  • Proven leadership experience in regulatory compliance and team management
  • In-depth knowledge of GxP, ISO standards, and FDA regulations
  • Experience implementing quality initiatives in a commercial manufacturing setting
  • Strong track record of managing change and leading teams through transformation
  • Ability to develop strategic plans and execute them effectively
  • Excellent communication and stakeholder management skills

Responsibilities

  • Lead the site Quality organization, ensuring expertise and leadership in Quality and GMP
  • Foster teamwork and innovation within the Site Quality organization
  • Develop and implement the Quality strategy aligned with company objectives
  • Maintain compliance with GMP standards and regulatory requirements
  • Drive continuous improvement initiatives in Quality programs
  • Oversee audits and corrective actions with partners and regulatory authorities
  • Create professional development plans for Quality staff to enhance skills and capabilities

Benefits

  • Opportunity to lead a dedicated team focused on quality innovation
  • Direct involvement and influence in shaping Quality strategies for the site
  • Work onsite with a leadership team in a dynamic environment
  • Access to continuous professional development and training opportunities
  • Engage with industry partners and regulatory authorities on vital quality issues
Full Job Description
The Senior Director, Head of Quality at our site leads a dedicated team focused on innovation and excellence. Seeking an ambitious leader to develop quality strategies. Key responsibilities: The Quality Site Head is a prominent member of the site leadership team and will be onsite mostly to support key responsibilities. - The Quality Head for the site, is the leading source of Quality and GMP related expertise within the site and is responsible for providing the strategic leadership and management for the Site`s Quality organization - Provide leadership to the Site Quality organization to ensure that teamwork, high morale and innovation are fundamental components of a team - Develop and execute the 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 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 GMP standards, corporate policies, FDA, EMA 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 - 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 Quality functions - Establish and maintain a positive working relationship with customers, the FDA and other regulatory authorities. Represent the Lonza on quality and cGMP compliance issues that are specific to the site - Serve as the company Quality expert, providing solid, well-informed, actionable Quality support to Operations, R&T, and other functions as requested Key requirements: - Commercial Manufacturing demonstrated experience. - Confirmed leadership experience in quality assurance and quality control within a GMP environment. - Deep expertise in GxP, ISO standards, FDA regulations, and quality compliance frameworks. - Proven change leader who drives adoption of new ways of working and aligns teams to transformation. - Ability to translate corporate strategy into critical success factors and executable implementation plans. - Demonstrated senior leader with sustained performance, including compliance remediation, turnaround experience, and budgeting. - Strong track record in developing and executing strategic quality initiatives. - Experience leading, developing, and influencing teams within a complex, matrixed organization. - Excellent problem‑solving skills with a results‑oriented, pragmatic, and urgency‑driven mindset. - Ability to manage multiple projects simultaneously while meeting aggressive deadlines. - Strong communication, negotiation, facilitation, mentoring, and stakeholder‑management skills. - Proven ability to promote a culture of empowerment, accountability, rigor, and effective issue escalation and reporting.

About Lonza America Inc

Lonza America Inc is a subsidiary of Lonza Group, a Swiss multinational company that provides products and services to the pharmaceutical, biotech, and specialty ingredients markets. Lonza America Inc is responsible for the North American market and offers a range of products and services, including custom manufacturing, research and development, and quality control testing. The company has a strong focus on sustainability and has implemented various initiatives to reduce its environmental impact. Lonza America Inc was founded in 1897 and has since grown to become a leading provider of products and services in the pharmaceutical and biotech industries.
Learn more about Lonza America Inc
Size
16,218 employees
Industry
NASDAQ

Similar Jobs

More Jobs at Lonza America Inc

More Pharmaceuticals & Biotech Jobs

Find similar Quality Site Head jobs: