Seagen

Senior Manager Quality Compliance

Description

Summary

The Sr. Manager, Quality Compliance is responsible for planning and conducting GMP quality audits supporting clinical and commercial programs. The role demonstrates a breadth of diverse leadership experiences and capabilities including the ability to influence and collaborate with peers, develop and coach others, and oversee and guide the work of colleagues to achieve meaningful outcomes and create business impact.

Principal Responsibilities:

• In accordance with Seagen standard operating procedures and quality policies independently plans/leads/conducts a wide range of routine and non-routine/complex internal and external audits including commercial/clinical manufacturing sites and contract manufacturers, with minimal oversight
• Assembles and coordinates activities of the audit team. Works with colleagues on cross functional GMP audit plans as required
• Communicates audit results to management and auditees through written audit reports.
• Advises business representatives (e.g. BPOs) on outcomes of audits and provides input to process improvement activities
• Leads post-audit activities, following up on any vital corrective and preventive actions.
• Acts as a reviewer of audit reports from outsourced or routine audits
• Assesses audit plans and quality metrics to identify potential areas of risk
• Represents Quality Compliance on cross-functional teams and initiatives
• Facilitates the Quarterly Audit
• Forum for monitoring vendor performance, trends and compliance
• Prepares and issues periodic vendor performance reports for Quality and/or Site Management.
• Collaborates with Subject Matter Experts to support vendor selection.
• Provides input into the development, and assists in the implementation, of the Auditor Qualification Program.
• Assists with training/orientation for new Quality Auditing staff.
• Coordinates auditor assignments and manages audit schedules, agendas, responses, reports, status updates, and audit closures
• Supports review and approval of audit reports, Qualified Vendor List and audit schedule.
• Provides input into appropriate KPIs and metrics. Uses and interprets qualitative/quantitative data to drive decision making
• Collaborates with team members to improve upon and streamline the current vendor auditing program and the vendor management processes. Leads and drive improvements as required.
• Revises and approves standard operating procedures and other controlled documents as necessary
• May assist with regulatory inspections by acting as a scribe, document reviewer, and/or SME.
• Represents Quality Compliance Auditing department during Regulatory and partner audits, and interact with auditors
• Delivers awareness sessions/trainings on various GMP topics, internally and externally
• Drives interactions with QA colleagues at other Seagen locations and organizations/functional groups to ensure consistency in application of Quality Compliance strategy and to promote standardization of auditing approach within Quality
• Actively engages in discussions to determine impact of changing needs of the regulatory environment
• Independently/with minimal supervision demonstrate leadership by providing recommendations to meet changing GMP business needs

Required Qualifications:

• 14+ years’ experience conducting Quality audits in a regulated environment
• Ability to interpret policies, standards and regulations, and evaluate potentially critical problems
• Must be capable of assessing compliance requirements using sound judgement and decision-making skills
• Demonstrated ability to lead, develop and build program infrastructure to support compliance activities and obligations to Health Authorities
• Demonstrated advanced knowledge in ICH and global regulations (e.g., FDA, EMA, HC, ANVISA, TGA) and international standards (e.g., ISO, WHO)
• Critical thinking expertise, with ability to define and implement a strategic approach to auditing based on compliance and business knowledge
• Independent decision making with a high degree of initiative
• Strong oral and written communication, collaboration, and interpersonal skills with the ability to influence others, facilitate team interactions, and partner with key stakeholders
• Innovative thinker and problem solver
• Ability to identify trends within data and apply insights to make recommendations and decisions
• Ability to work with ambiguity and demonstrated flexibility, adapting strategy when needed
• Experience evaluating and understanding quality standards and their application.
• 25% - 40% domestic and international travel is required

Preferred Qualifications:

• Bachelor’s degree in a scientific discipline or equivalent education and experience
• 7+ years prior auditing experience as a lead GMP auditor in pharmaceutical, biologics or medical device industry. Experience in leading audit teams (2-6 people per team)
• Experience with commercial drug product operations including injectable parenterals, finished goods production, API and excipient manufacturing, and analytical testing
• Expertise in GMP and biotech focus areas such as analytical testing, aseptic manufacturing, sterile injectables, low bioburden etc. Has domain expertise in 2 or more technical areas
• Ability to function autonomously in a matrix model and in a team environment

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.

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.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 03/05/2021