Seagen
Associate Director Global Safety Compliance
Development - Remote, Bothell, United States
Description
Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!
Summary:
The Associate Director, Global Safety Compliance is responsible for supporting the development and maintenance of Drug Safety processes and procedures that ensure compliance with global regulatory requirements. This position also participates in the development and maintenance of Drug Safety process training, including the support of training delivery to Drug Safety and cross-functional personnel as required. This role will lead and facilitate GvP audit and inspection activities.
Principal Responsibilities:
- Independently manage the process that guides the authoring, review/approval, and change management of Drug Safety process documents in partnership with cross-functional departments
- Provide support to Global Safety Compliance function to identify risks and risk mitigation strategies
- Design a due diligence process for evaluation of vendors/business partners, in collaboration with Seagen Vendor Strategy Management (VSM) and Research & Development Quality (RDQ) functions
- Collaborate with key stakeholders to ensure inspection and audit readiness of GSRM staff
- Leads audit/inspection activities in close partnership with Global Safety
- Compliance both as SME and support role
- Serve in an advisory/consultative role in compliance related matters and support internal team as such
- Participate in periodic quality review of data to identify opportunities for process improvement
- Directly engage with internal functions and vendors to identify root cause of any regulatory compliance risks and establish corrective plan and execution
- Open and investigate Quality Events, Deviations and CAPAs
- Diligent follow through with any audit/inspection observations to ensure timely action and completion
- Participate in documentation of change control
- Support Global Safety Compliance in Quality Management System (QMS) compliance activities as required by GvP regulations
- Experience in creating and negotiating Pharmacovigilance Agreements and/or Safety Management plans
- Experience with Pharmacovigilance training
- Perform other duties related to the position as required
Qualifications:
- 10+ years of experience in Drug Safety Compliance, Quality Management and/or related area
- Ability to work independently with limited supervision and/or input into work methods
- Demonstrated ability to manage complex processes and use experience and judgment problem solving and solution development
- Superb communication (verbal and written) skills
- Demonstrated knowledge of domestic and international regulatory safety reporting requirements
- Comparable experience in the pharmaceutical industry experience preferably in one or more of the following areas: Drug Safety, Clinical Operations, Quality Assurance or Regulatory Affairs
- Excellent organizational skills and attention to detail
- Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally
Education:
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 $184,000 to $237,600 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.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 02/03/2023
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