Seagen

Seagen is a global multi-product biotechnology company that develops and commercializes innovative therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to four marketed products, we are advancing a strong product pipeline of novel therapies for solid tumors and blood related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients. More information about Seagen can be found at www.Seagen.com 

Position Summary: 

The Senior Manager of External Quality – Team Lead establishes and maintains the Quality oversight of third-party suppliers of clinical and commercial Drug Substance and Drug Product manufactured globally to ensure an uninterrupted supply of product meeting global regulatory standards. This role will serve as the primary Quality Point of Contact for all matters pertaining to external manufacturing of commercial and clinical products for Seagen.

Principal Responsibilities:

• Manages and leads the External Quality team responsible for all aspects of external manufacturing at Seagen Contract Manufacturing Organizations (CMOs)
• Owns the quality oversight of CMOs for commercial and clinical products globally manufactured on behalf of Seagen, ensuring on-time delivery of products in compliance with corporate, domestic, and international policies and regulations
• Provides leadership to Global External Quality staff. The incumbent is able to recruit, develop and retain first class self-driven talent into their function
• Manages regular quality meetings at CMOs to discuss performance, risks, and opportunities to drive continuous improvement and join Operations Review Meetings as per schedule
• Serves as the primary quality POC and Subject Matter Expert (SME) for all matters pertaining to clinical and commercial manufacturing including regulatory inspection support at third-party suppliers and headquarters
• Serves as an advocate for the organization while maintaining good relationships with external teams and responsible for escalation of problems, disputes or questions
• Develop, monitor, and maintain positive business relationships with CMOs and partners to encourage collaboration, improvements, transparency, and accountability
• Is a collaborative partner with other Quality and TOPS leaders. The incumbent is able to foster cooperation across multiple organizational functions, sites and levels
• Develop, negotiate and maintain Quality Agreements with CMOs and ensure compliance with agreements
• Oversee complex investigations in partnership with CMOs and report to Seagen’s Material Review Board and cross-functional teams
• Develop/maintain quality risk management plans; utilize risk management tools, such as risk register, to identify and mitigate CMOs quality and compliance risks, ensuring CMO sites are in a state of continuous inspection readiness
• Provide as needed support during regulatory inspections and cGMP compliance audits, collaborating with CMOs to ensure on time closure of associated CAPAs when requested
• Hold CMOs accountable and address gaps of audit responsiveness, CAPA implementation, deviation reporting and management, investigation closure, and change implementation with regards to quality and time with the CMO; and escalate as appropriate
• Monitor and assess CMO‘s key performance and quality indicators to propose Continuous Improvement initiatives
• Collaborate and manage relationships across CMO management and internal governance teams to assure quality expectations are aligned and support joint improvement goals
• Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance
• Troubleshoot and direct the resolution of quality issues, fostering effective interdepartmental and cross-functional partnerships
• Review and approve process validation protocols and reports
• Set group performance goals and provide input to departmental objectives.
• Maintain and communicate work priorities to meet goals and timelines
• Communicate new and updated regulatory requirements and applicable Seagen expectations to CMO, as applicable, and evaluate systems in place

Required Qualifications:

• Minimum of Bachelor’s degree in a scientific discipline (Chemistry, Microbiology, etc.) – EU 12+/ US 14+ years experience in the pharmaceutical industry, with 5-10 years in QA and 3+ years of people management.
• Ability to travel domestically and internationally 20% of time
• At least 12 to 14 years relevant GMP Experience

Preferred Qualifications:

• Experience with the production of Biologics Drug Substance and Drug Products (Antibody Drug Conjugates experience preferred) and/or, as alternative, Small Molecule APIs and Drug Product as Oral Solid Forms
• Has a bias for action and displays a sense of urgency. Must possess strong skills in leadership, motivation and mentorship
• Able to carry out difficult decisions in a logical, rational manner
• Demonstrated ability to work as a senior team member and to engage and influence team members in a matrixed environment
• Ability to work well in both internal and external teams, including experience in virtual teams
• Should possess a flexible risk-based approach to problem solving and be an adept negotiator
• Self-motivated, flexible, adaptable, focused and persistent
• Excellent communicator both verbally and in writing with all levels of staff, both inside and outside of the organization
• Ability to work in a fast-paced environment
• Ability to prioritize work and handle multiple assignments, while maintaining a high level of quality
• A thorough knowledge and appropriate application of GMPs and other regulations applicable to U.S. and international regulatory agencies
• Must be capable of assessing compliance to quality requirements using sound judgement and decision-making skills
• Experience in managing and working with CMOs
• Excellent verbal and technical written communication skills, excellent interpersonal skills, and negotiation skills are essential
• Innovative, proactive, and resourceful; committed to Quality and continuous improvement

As a leading employer in our industry, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. To learn more about Seagen, please visit www.Seagen.com.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment. 

#LI-LO1