Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

Summary of Job:

The Sr. Manager – Environment, Health, and Safety (EHS) will play a critical role in providing tactical direction and leadership for safe and environmentally compliant drug substance manufacturing at the new Kyowa Kirin North America monoclonal antibody drug substance manufacturing facility in Sanford, NC.

Initially, the Sr. Manager will be an individual contributor but will later manage an EHS specialist.

During the facility's startup phase, the Sr. Manager will develop training programs, safety policies and procedures, and implement curricula and learning plans for the site. Additionally, they will be heavily involved in facility construction and startup activities to ensure a safe and injury-free environment.

The Sr. Manager is responsible for acting on behalf of the company, specifically regarding the promotion of safe, professional work practices and conditions that comply with environmental, health, and safety policies and regulations.

It is the Sr. Manager's responsibility to ensure that all employees follow safety protocols and procedures. This includes conducting safety audits, investigating and reporting incidents, and developing safety programs.

As a people leader, you will embody compassionate, people-centric leadership to guide and support our team. You will collaborate closely with others, fostering a collaborative, inclusive, and supportive environment while driving team development. Your work will reflect the organization’s values and integrity in all your actions. Utilizing situational leadership and emotional intelligence, you will align diverse viewpoints, manage stakeholders, and make empathetic decisions to effectively address individual and team needs. You will also be results-oriented, ensuring that your team not only adapts to challenges but also delivers measurable outcomes aligned with business objectives. Additionally, you will help teams navigate change and uncertainty with resilience and clarity, enabling them to adapt to fast-evolving, rapidly scaling environments and meet new challenges in the biotech industry with a patient-focused mindset.

Essential Functions:

Developing and implementing policies: Create and implement policies, procedures, and programs to ensure workplace and environmental safety.
Ensuring compliance: Ensure the organization complies with local, state, and federal regulations.
Training employees: Lead employee training on safe work practices and safety procedures.
Conducting audits and investigations: Conduct safety audits, report incidents, and investigate accidents.
Regulatory reporting: Compile and submit accident and annual reports to regulatory agencies. Act as the site lead for internal and external safety audits.
Communicating with stakeholders: Communicate with other departments and stakeholders to explain policies and procedures.
Advising management: Provide advice to management on the environmental, health, and safety impacts of operations.
Protecting the company's reputation: Protect the company's reputation by ensuring ethical practices, complying with regulations, and fostering a strong safety culture.
Developing management systems: Build systems to measure compliance and performance, ensuring continuous improvement.
Preparing applications: Prepare applications for permits to install, operate, or modify pollution control systems.
Implementing waste handling systems: Implement waste handling and treatment systems to reduce costs and waste.
Safety culture: Work to improve the safety culture throughout the organization.

People Leadership

Results-Oriented: Lead teams by setting clear, measurable goals and ensuring accountability for achieving key objectives. Align resources effectively, remove obstacles, and maintain focus on delivering high-quality results within established timelines.
Empathetic Communication: Listen carefully, provide constructive feedback, and handle conflicts with care.
Team Development: Mentor and guide team members, create growth plans, support ongoing learning, and develop the team with a patient-focused mindset.
Inclusive Leadership: Build a diverse and respectful environment where everyone feels valued and supported.
Supportive Environment: Encourage a positive workplace, celebrate achievements, and promote work-life balance.
Collaboration: Lead by example, promote teamwork and respect, and ensure your actions reflect the organization’s values.
Emotional Intelligence: Manage emotions thoughtfully, make empathetic decisions with a patient-focused mindset, and remain calm under pressure.
Change Management: Help teams navigate change through clear communication and flexibility
Stakeholder Management and Consensus Building: Work with diverse individuals to build alignment, guide discussions toward common goals, and ensure decisions reflect a patient-focused mindset
Situational Leadership: Adapt your leadership style to meet the needs of the team, offering guidance or independence as needed while keeping patient outcomes in mind.

Job Requirements:

Education

Bachelor's degree in occupational health & safety management or environmental management, or related field; advanced degree preferred

Experience

10+ years progressive EHS experience in a manufacturing environment; pharmaceutical manufacturing experience is a plus
Demonstrated leadership and teamwork skills
Excellent analytical and communication abilities

Skills

Energetic leader with a proven ability to lead change initiatives; demonstrated interpersonal skills to effectively interact with individuals of all disciplines and levels within and across the organization; ability to think strategically and critically analyze details from multiple, disparate sources; capable of consistently taking the initiative to get things accomplished; able to apply appropriate situational leadership techniques to adapt to current situations; competent in evaluating people's strengths and areas for improvement, and mentoring/coaching for enhancement.
Comprehensive understanding of EHS regulations and requirements.
Excellent written, oral, and interpersonal communication skills.
A team builder with action orientation and the ability to influence staff across the organization.
Action-oriented decision maker.
Experience supervising, leading, and developing EHS professionals.
Experience with process improvement tools such as Kaizen.
Strong focus on behavioral safety and employee engagement.
High integrity.
Ability to influence up and down within an organization.
Startup experience is a plus.
Experience with implementing EHS management systems including ISO 14001 and OHSAS 18001 (ISO 45001).
Experience with OSHA VPP preferred.
Certified Safety Professional (CSP) or other EHS professional certification is preferred.
Customer-focused and a strategic thinker; must have the ability to lead change and possess strong consultative and influencing skills.
Excellent oral, written, and interpersonal skills are essential.
Demonstrated experience leading the implementation of EHS management systems.
Demonstrated experience leading positive culture change.
Experience interfacing with government agencies to maintain regulatory compliance and engagement.

Technical Skills

Proficient in MS Office Suite
Proficiency with environmental / safety incident investigation generation and CAPA tracking

Leadership Skills

Proven leadership experience with a focus on results and teamwork
- Integrity and respect for people
- Effective communication and interpersonal skills
- Ability to mentor, develop, and support team members
- High adaptability and emotional intelligence
- Inclusive and empathetic
- Ability to deal with ambiguity
Non-Technical Skills
Demonstrate empathetic communication by actively listening and considering others’ perspectives to foster productive and engaging interactions, while managing relationships with kindness and care. Embrace personal growth through continuous learning and sharing knowledge, maintaining a growth mindset. Foster inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by acknowledging achievements and promoting healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Be resourceful and proactive in challenging the status quo, driving innovation, and developing creative solutions. Maintain a results-oriented approach by setting clear goals, tracking progress, and ensuring your actions consistently lead to measurable outcomes that advance organizational objectives.Respond promptly, take accountability, and manage tasks efficiently. Adapt to change with clarity, patience, and understanding, guiding the team through evolving challenges. Exhibit strong organizational skills, attention to detail, and a solid work ethic, while demonstrating cultural sensitivity and the ability to build alignment in a global environment. Maintain an enterprise-wide, holistic mindset, working beyond siloed thinking to drive cohesive, integrated solutions.

Physical Demands: Work is 100% on-site in Sanford, NC; this is not a hybrid nor remote role

Working Conditions: Requires up to 10% domestic and limited international travel

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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Sr. Manager – Environment, Health, and Safety (EHS)