Job Opportunity

Job Opportunity

Sr. Director/Director, Cranbury QA Head

Sr. Director/Director, Cranbury QA Head

United States Posted 2024-10-18

Job Title - Senior Director/Director, Cranbury QA Head

Job Location - Cranbury, NJ

WuXi Biologics is a global leader in biologics, offering end-to-end solutions for the discovery, development, and manufacturing of biologics. Our success is driven by our employees and a PROUD culture of Passion, Reward, Opportunity, Unity, and Determination. With over 12,000 employees, we serve 600+ customers, including the top 20 biopharma companies worldwide.

Job Summary: The Quality head will lead the quality functions within the organization, ensuring that all Biologics products are produced in compliance with cGMP regulations, industry standards, and client expectations. The role encompasses strategic planning, leadership, and management of the Quality Assurance (QA) and Quality Control (QC) departments.

Responsibilities

Provide expert guidance and leadership in quality management systems (QMS), ensuring compliance with industry standards, regulatory requirements, and company policies.
Regulatory Compliance: Oversee compliance with cGMP guidelines and ensure readiness for regulatory inspections by health authorities (such as the FDA, EMA) and clients. Keep abreast of regulatory updates and implement necessary changes in quality systems and procedures.
Quality Systems Management: Develop, implement, and maintain a robust quality management system (QMS). Ensure the proper documentation, including SOPs, batch records, and validation reports, is maintained.
Quality Assurance: Provide leadership and direction to the QA team, including oversight of batch release, change control, deviations, CAPA, and risk management. Review and approve master and executed batch records and manage product release processes.
Quality Control: Ensure the QC labs are equipped and managed to support in-process, release, and stability testing of WXB products. Oversee method development, validation, and transfer activities.
Supplier and Material Management: Qualify suppliers and manage quality agreements. Oversee the quality of raw materials and other components used in the manufacturing process.
Client Interaction: Liaise with clients regarding quality-related communications. Participate in client audits and respond to audit observations.
Operational Excellence: Drive continuous improvement initiatives within quality operations. Collaborate with other departments to resolve quality issues and improve overall operational efficiency.
Strategic Planning: Participate in strategic planning for company growth from a quality perspective. Ensure quality considerations are addressed during the development of new services.
Provide cross functional support to internal XDC departments to ensure sustainability and continuous improvement in all compliance and quality functions.
Provide leadership and guidance to immediate staff directing Quality functions.
Manage performance and development of direct reports to ensure achievement of organizational and department goals and a productive environment.
Manage and administer all aspects of people processes related to the employee lifecycle. This includes the selection, hiring and training of personnel on company and department policies, systems and processes. Manage and communicate compensation related information per company guidelines
Establish performance metrics and conduct performance evaluations.
Coach and develop staff by providing an environment that encourages ongoing personal and professional growth. Manage and ensure the setting of realistic personal goals for staff and provide regularly scheduled feedback throughout the year. Ensure staffs receive appropriate knowledge and skill development and growth opportunities.
Serve as a quality subject matter expert, representing the organization in external audits, regulatory inspections, and industry forums.
Work closely with research and development teams to ensure quality considerations are included in new product design and development.
Review and approve critical documents, such as validation protocols and reports, standard operating procedures (SOPs), and technical reports.
Facilitate risk management activities, including risk assessments and mitigation plans, to anticipate and address potential quality issues.
Analyze data trends and key performance indicators (KPIs) related to quality, using insights to inform strategic decisions and resource allocation.
Representing the company to external parties with focus on GMP compliance.
Recruiting and management of Global Quality System & Compliance Staff.
Preparing budget and management of expenditure in line with budget for quality functions and activities.
Approval, and where required preparation, of capital expenditure requests for site improvement and renovation projects.

Qualifications:

Extensive experience in quality roles within a GMP-regulated biopharmaceutical or CDMO environment, specifically with experience in antibody-drug conjugates or biologics.
Experience with audit management and interaction with regulatory inspectors
15+ years experiences in Pharmaceutical Industry.
10+ years experiences in Quality Management.
Thorough understanding of Biologics drug development and manufacturing processes.
Strong knowledge of global regulatory requirements and experience interacting with regulatory authorities.
Knowledge In FDA/EMA/CFDA GMP regulations, Pharmacopoeias, and ICH guidelines, and USP/EP/CH.P.
Knowledge and experiences in Quality Assurance (QA) and Quality Control (QC) in Pharmaceutical/ Bio Pharmaceutical industry.
Bachelor degree or above in Chemistry, Biochemistry, Biology, Pharmaceutical. Biological Engineering, or related field.
Proven leadership and team management skills.
Proven experience in leading quality initiatives and driving process improvements.
Excellent analytical, statistical, and problem-solving skills.
Ability to effectively communicate and influence at all levels within the organization
Detail-oriented, with a commitment to achieving the highest quality standards.
Excellent communication and interpersonal skills to effectively manage client relationships and lead a diverse team.
Analytical and problem-solving abilities to address complex quality issues.
Commitment to maintain high-quality standards and enhance client satisfaction.
May require occasional travel to meet with clients, attend conferences, or oversee external activities.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

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