Seagen

Manager Compliance & Assurance - Launchpad

Corporate Functions - Bothell, United States

Summary:

Seagen’s new cGMP manufacturing facility “project Launchpad” is being built in Everett, Washington, just North of Seattle. Launchpad will be a greenfield build encompassing end-to-end manufacturing capabilities for biologics and antibody-drug conjugates (ADCs).

Seagen Real Estate and Facilities (REF) is accountable for compliance with all applicable regulations including but not limited to cGxPs, state and local environmental and safety regulations and internal Seagen business processes.

Responsibilities:

• Scope of Principle Responsibilities - This position will work with a cross functional team of individual contributors, managers and associate directors from Facilities, Manufacturing, QC, GLP and QA. In addition to tactical decisions based on established procedures and precedents, this role is expected to gather information, query stakeholders and then make strategic decisions which have site-level impact. This role will work with C&A Senior Manager and other site C&A Managers on programs and projects that have cross-site and global impact. This position does not have direct reports but will lead teams and provide on-the-job mentoring and training to REF C&A Associates II, III and Sr.
• Accountable for ensuring their site is compliant with companywide policies and procedures
• Represents compliance interests on respective REF Site Governance Committee
• Responsible for performing Facilities related deviation investigations, CAPA, change controls including operating procedure creation and revision.
• Maintains site in state of audit readiness by producing audit materials, training new audit team members and acting as a system owner including writing audit responses and carrying out corrective actions based on findings
• May own and maintain validated computer systems, e.g. computerized maintenance management systems or equipment monitoring system
• Serves as a research engine and a repository of knowledge on applicable regulations
• Models' strong compliance commitment through behaviors, thought processes and skills
• Alerts business units to emerging regulatory trends
• Reduces risk, provides business continuity by promoting good documentation processes (GDP)
• Advises REF business units on appropriate levels of risk
• Lead cross-functional business monitoring exercises
• Builds compliance skills within REF business units to enable highest quality work and documentation

Qualifications:

• Bachelor of Science in engineering, pharmaceutical science or other relevant life science discipline or equivalent
• Minimum of 5 years' experience at a senior level in biotech or pharmaceutical operation with specific experience in technical services/engineering, EHSS, supply chain, quality control or manufacturing operations including familiarity with regulatory compliance
• Experience in audit and assurance including proven record of accomplishment interacting with authorities and executive leaders, leading investigations, developing CAPAs and performing audits
• Expertise in various methodologies of investigation to drive desired outcomes
• Strong understanding of validated computer systems and system administration
• Demonstrated understanding of GxP regulations and compliance of biopharmaceutical manufacturing and ability to effectively support GxP operations
• Must have a minimum of 3-5 years’ experience leading deviation investigations, CAPA, Change Control, participating in audits or related quality management activities
• Multi-national, multi-site and global standards experience

Preferred Qualifications:

• Experience working with Data Integrity
• Experience working with validated computer systems
• Experience with leading continuous improvement initiatives and documenting processes
• Experience in risk assessment and risk management
• Strong leadership, collaboration and influencing skills with demonstrated ability to problem solve and drive positive change
• The ability to communicate broadly and demonstrated experience in understanding of business value drivers
• Experience working in a manufacturing

As the leading employer in our industry in the Pacific Northwest, 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. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.

The hiring pay range for this position is $117,000 - $152,000 per year based on skills, education, and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 03/03/2023