Associate Director, External Quality Operations

Associate Director, External Quality Operations

Seagen

Zug, Switzerland

Description

The Associate Director of External Quality Operations is responsible for all quality aspects associated with the manufacturing operations across a portfolio of Contract Manufacturing Operations (CMO) network. You will lead a team of seasoned quality professionals responsible to establishing and maintaining the Quality oversight of third-party suppliers of both commercial and clinical intermediates, BDS, and DP to ensure an uninterrupted supply of product distributed globally. This role will serve as the primary quality Point of Contact for all matters pertaining to commercial and clinical manufacturing, including establishment of a CMC network and expertise in the regional regulatory and quality landscape.

Principal Responsibilities

• Manages and leads the ESO Quality team in Zug responsible for all aspects of manufacturing, packaging, and testing, including technical batch release as applicable
• Accountable for the quality oversight of third-party suppliers of commercial intermediates, BDS, and DP, ensuring on-time delivery of products in compliance with all applicable international policies and regulations
• Facilitates disputes pertaining to quality or compliance to reach swift resolution
• Manages regular quality meetings at CMOs to discuss performance, risks, and opportunities to drive continuous improvement
• Serves as the quality single point of contact (SPOC) and Subject Matter Expert (SME) for all quality matters pertaining to commercial manufacturing at CMO including regulatory inspection support at third-party suppliers or at HQ
• Coordinate cross-functional activities between the CMOs, partners, and stakeholders to enable execution and efficient disposition of batches
• 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
• Establishes a CMC network, understands and shares the regional regulatory and quality landscape. Participates and presents in key industry meetings, is an influential Quality voice
• Strategically scales resources to maintain an efficient and flexible operation according to commercial demands
• Provides leadership to local Quality staff. Is able to recruit, develop and retain first class self-driven talent into their function. Is a collaborative partner with other Quality and TOPS leaders
• Is able to foster cooperation across multiple organizational functions, sites and levels. Responsible for communicating quality issues to the External Quality management and driving their resolution successfully
• Responsible for leading strategic initiatives to continuously improve and adapt the External Quality business processes within Quality
• Manage the periodic management reviews with CMO and internal Seagen stakeholders, ensuring the reviews are documented and that appropriate corrective and preventive actions are identified and implemented for each CMO
• Recruit, retain and develop QA/QC talent responsible for the management of quality operations to ensure the compliance of all products.
• Develop performance goals and objectives for the assigned team; drive and monitor performance against objectives
• Sustain employee engagement by creating a culture of excellence and an environment in which individuals and teams can excel and continuously improve in a diverse environment
• Manages the utilization of Quality resources to ensure on-time supply of products and adherence to financial targets

Qualifications

• Minimum Bachelor’s degree in a scientific discipline (Biotechnology, Chemistry, Microbiology, Pharmacy ) – 10+ years experience in the pharmaceutical industry, with 5-10 years in QA and 3+ years of people management
• Experience with the production and testing of biologics/sterile injectable preferred
• Should have demonstrated knowledge and experience in the interpretation and application of cGMPs and ICH requirements for both domestic and international territories
• Must possess strong skills in leadership, motivation and mentorship
• Able to carry out difficult decisions in a logical, rational manner, and 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
• 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
• Ability to travel frequently within Europe as well as occasional travel to the Corporate HQ in Seattle

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Switzerland     Manager and Executive     Manufacturing and Logistics     Quality Assurance     Seagen