Senior Manager, Quality Control

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 translate science into smiles by delivering therapies where no adequate treatments currently exist working from drug discovery to product development and North America we are headquartered in Princeton NJ with offices in California North Carolina and Mississauga Ontario.

Summary of Job:

The Senior Manager Quality Control will play a critical role in designing developing and executing the operational readiness program for the start-up of the Quality Control laboratories at the new Kyowa Kirin North America monoclonal antibody drug substance manufacturing facility in Sanford NC.

You will lead and enable the timely completion of key milestones to ensure production targets are achieved. This role will initially work in a greenfield environment and will transition to lead laboratory operations throughout GMP readiness technology transfer and facility licensure activities supporting the manufacturing of Phase III and early commercial products. You will be accountable for ensuring compliance of the Quality Control laboratories with current GxP standards and all applicable Global Regional and Site procedures within Kyowa Kirins Quality Management System.

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 organizations 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 address individual and team needs effectively. You will also be results-oriented ensuring that your team not only adapts to challenges but also delivers measurable outcomes that align 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

Technical Skills Knowledge and Experience

Provide technical leadership collaborating cross-functionally in the sites early-stage activities including: facility detailed design review; facility equipment and analytical instrument user requirements review; prioritization for implementation of equipment instruments and analytical methods required for facility start-up (GMP Ready/OQ Complete); and ICT efforts for developing user requirements and procuring selected electronic Quality Systems for operations (LIMS/ELN/Empower).

Establish and maintain Quality Control procedures as applicable to the Site QMS Laboratory Controls Sub-system and develop training requirements for QC staff.

Lead and coordinate cross-functionally the robust compliant and timely implementation of all required analytical and microbiological test methods by ensuring completion of the required steps from method development qualification/optimization validation or suitability for compendial methods and/or transfer.

Establish a Raw Materials sampling testing and release program in compliance with all applicable regulatory requirements (JP USP EP etc.).

Coordinate testing and reporting of laboratory results in support of the facility Environmental Monitoring and Utility Monitoring programs.

Lead QC laboratory operations to achieve all required validation and qualification activities for the facility equipment analytical instruments and computerized systems required for project commissioning and operational readiness for start-up.

Ensure laboratory electronic systems and records are compliant with current 21 CFR Part 11 and Data Integrity (ALCOA) requirements.

Hire onboard train and mentor QC staff per approved staffing plans.

Lead and ensure the timely investigation of deviations laboratory exceptions or other cGMP issues at the site and initiate and communicate corrective and preventive actions (CAPA) for resolution working cross-functionally.

Establish key performance indicators for the QC laboratories (e.g. OOS Invalid Assays OOT Laboratory Deviations Testing Turnaround Times EM Data Trends etc.).

Implement and manage the Contamination Control Strategy (CCS) for the site working cross-functionally.

Assist the Quality Site Head in identifying and qualifying contracted laboratory services and/or contingent staffing as required (Disinfectant Efficacy Studies Mycoplasma in vitro adventitious virus testing). Lead QC laboratory activities required to successfully respond to regulatory requests and support regulatory and internal inspections of the facility and laboratory areas.

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 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 organizations 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 with clear communication and flexibility.

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.

Stakeholder Management and Alignment Building: Work with diverse stakeholders to build alignment guide discussions toward common goals and ensure decisions are made with a patient-focused mindset.

Education

Bachelors degree in a life science or related field (minimum).

Masters degree in a life science or related field (preferred).

Experience

Five (5) or more years of management experience leading GMP biopharmaceutical Quality Control laboratories and associated support areas including QC Sample Management Microbiology Raw Materials Chemistry/Biochemistry Stability Bioassay and/or Virology.

Experience supporting the start-up and operation of a biopharmaceutical manufacturing facility is preferred.

Technical Skills

Proficient in Empower LIMS ELN LES Microsoft Office Suite Lean Lab practices and Agile methodologies.

Non-Technical Skills

Results-oriented and able to navigate ambiguity you set clear outcomes track progress follow through on commitments and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly take accountability and manage tasks efficiently. Adapt to change with clarity patience and resilience guiding teams through evolving challenges. Demonstrate strong organizational skills attention to detail and a solid work ethic while exhibiting cultural sensitivity and fostering alignment in a global environment. Communicate with care by actively listening and considering others perspectives fostering productive and engaging interactions and building relationships with empathy and respect. Embrace continuous learning and knowledge sharing while maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect integrity and humility prioritizing collective success over individual gain. Be resourceful and proactive by challenging the status quo driving innovation and developing creative solutions. Apply an enterprise-wide holistic mindset working beyond siloed thinking to deliver cohesive integrated solutions.

During the construction and start-up phases employees are required to wear appropriate personal protective equipment (PPE) including hard hats safety glasses steel-toe boots and high-visibility vests. Once transitioned to the GMP laboratory environment PPE will include lab coats gloves safety goggles and other equipment as defined by site safety protocols.

While working at our onsite corporate facility employees are required to wear appropriate business attire in accordance with the companys standard dress code.

If traveling between both sites employees should be prepared to comply with the PPE and dress code requirements applicable to each location.

Reasonable accommodations will be provided as required by law.

This position is based onsite in Sanford NC. Standard company policies regarding flexible work arrangements do not apply to this role. This is not a hybrid or remote position.

May require up to 10% domestic and limited international travel.

Compensation & Benefits

The anticipated annual salary for this position is $137300 to $185000. The actual salary offered at the commencement of employment may vary based on several factors including but not limited to relevant experience skill set qualifications education (including applicable licenses and certifications) job-related knowledge geographic location and other business and organizational needs.

The listed salary range is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

401(k) with Company Match
Annual Bonus Program (Sales Bonus for Sales Positions)
Generous PTO and Holiday Schedule including Summer and Winter Shut-Downs
Sick Days
Volunteer Days
Healthcare Benefits (Medical Dental Prescription Drug and Vision)
HSA & FSA Programs
Well-Being and Work/Life Programs
Life & Disability Insurance
Concierge Services
Long-Term Incentive Program (subject to job level and performance)
Pet Insurance
Tuition Assistance
Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Equal Employment Opportunity

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 individuals without regard to race religion creed color pregnancy sex age national origin disability genetic trait or predisposition veteran status marital status sexual orientation or affectional preference citizenship status or any other characteristic protected by applicable law.

Applicant Privacy Notice

When you apply for a position through this site the personal data contained in your application will be collected and stored by Kyowa Kirin Inc. (Controller) located at 510 Carnegie Center Drive Princeton NJ 08540 USA. The Controller can be contacted by emailing .

The Controllers Data Protection Officer can be contacted at .

Your personal data will be processed for the purposes of managing the Controllers recruitment-related activities including setting up and conducting interviews and assessments evaluating applicants and supporting recruitment and hiring activities. Such processing is legally permissible under Article 6(1)(f) of the General Data Protection Regulation (EU) 2016/679 (GDPR) as necessary for the legitimate interests pursued by the Controller including the solicitation evaluation and selection of applicants for employment.

Your personal data will be shared with Greenhouse Software Inc. a cloud services provider located in the United States and engaged by the Controller to manage its recruitment and hiring process. Accordingly if you are located outside the United States your personal data will be transferred to the United States once submitted through this site. The transfer will be made using appropriate safeguards including standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by the Controller for as long as necessary to evaluate your application for employment. Under the GDPR if you are located in the European Union you have the right to request access to your personal data request correction or deletion of your personal data request restriction of processing exercise your right to data portability and lodge a complaint with an appropriate EU supervisory authority.

If you have questions regarding the use of your personal data please contact .

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless the agency has been engaged directly by Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location. Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-TT1