Job Detail

Description

Position Summary:

Reporting directly to the Vice President & Global Head of Quality, the Director of Business Operations and Strategy will operate at a strategic, operational, and tactical levels to enhance the effectiveness of the Quality organization.  In this role, you will ensure that the VP and the Quality Leadership Team are spending their time effectively to achieve the strategic objectives of the organization.  The Director of Business Operations and Strategy will be responsible for thought leadership and lead the development and delivery of a variety of strategic Quality projects and global initiatives by playing a critical role in enabling strategy execution, communication, and collaboration across the Quality organization. You will work closely with the Global and extended Quality leadership teams in driving the rhythm of the business and managing key reporting activities for the organization.  In this context, you will be expected to think holistically and strategically about all aspects of the global Quality strategic operations, key operational rhythms, business and governance processes, procedures and enable effective execution.  In addition, you will be focused on continuous improvement and operational effectiveness by using your insights and expertise to proactively identify issues which might impede business successes and implementing appropriate and timely mitigation plans. 

Principal Responsibilities:

• Serves as a strategic thought partner to the Global Quality Head, and the QA Leadership Team, giving input on current and future initiatives, strategic imperatives, cross-functional projects, human capital, and organization budgets to ensure optimal operating environment


• Supports Global Quality Head’s efforts to foster cohesion amongst QLT members. Connect the dots across the functional Quality groups for improved alignment and engagement


• Ensures Global Quality Head is informed and well prepared for all meetings and calls, including gathering information, providing advice, and synthesizing feedback from others as necessary


• Documents and maintains information for the Global Quality Head use including project timelines and reports related to governance meetings, operational/financial reviews, talent review, etc.


• Leads and/or guides the team for key strategic initiatives including the Quality road map, development of risk management strategy, risk mitigation and support strategies


• Looks across Quality functions to identify synergies and interdependencies to ensure optimal working model across all sites and functions


• Organizes, plans, and chairs the periodic Quality Leadership Team meetings (QLT, eQLT). Drives the agenda and the objectives of the topics placed on the agenda, conducts pre-meetings so that decisions are properly framed and as many points as possible are pre-negotiated


• Monitors progress toward delivery of the Quality strategic imperatives and objectives, intervening as necessary to ensure that the organization is on track to meet or exceed its performance targets


• Lead and coordinate the preparation of the Executive Quality Management Review for the company, and conducts pre-meetings to ensure all information are available to the Global Head of Quality


• Drives a culture of collaboration across Quality and contribute to creating and maintain a culture and values which attract, retain, and develop the most effective people


• Prepare presentations for the Global Head of Quality for various forums, including internal townhalls and external speaking engagements. Review internal company communications to assure they align with the Global Quality Head’s and stakeholders’ expectations


• Ensures compliance with all applicable SeaGen’s SOPs, local and international regulations, and industry best-practice


• Representing Quality in cross-functional teams, including inter-departmental where appropriate

Required Qualifications:

• 10+ years of experience working in biopharmaceutical industry, with specific focus on Quality operations, Quality Compliance and/or project management


• Demonstrated ability to influence executive leadership on complex technical and quality related topics with attention to detail and desire to achieve team and individual goals


• Excellent verbal and written communication skills (technical reports, professional reports, presentation, and emails)

Preferred Qualifications:

• BS/BA in science, biology, chemistry, or pharmaceutical studies


• Prior Experience in Quality Assurance, QC, Quality Systems, or Compliance is a plus


• Strong project management skills and experience managing multiple projects at the same time is essential