Director, Quality Control

Job Description

Develop and manage a global QC department to support the operations for the release and stability testing laboratories. The department consists of global groups for critical Reagent and Reference Standard Management, Global Raw Material strategy, Contract Laboratory Organization and Partner Management including Planning and Scheduling, Instrument Strategy, and Enterprise System Management. The department is focused on building strategic relationships with Global QC, key interal and external customers and partners, IT and Senior Leadership to support the daily operations of the testing laboratories. The responsibility of the department include harmonizing and streamlining processes, ownership and maintenance of SmartQC and LabWare LIMS, oversight of global projects, oversight of CAPEX budget, instrument purchases, instrument validation, raw material strategy and qualification of critical reagents, controls and reference standards globally.

What You’ll Do

· Identify, define and drive improvement projects for maximizing efficiency, streamlining processes, and increasing productivity in Global QC (ex. iQC)

· Represent QC on global strategic initiatives/projects within Quality Control (ex. IT and Manufacturing)

· Manage and develop direct reports and their teams. Define Roles and Responsibilities for global groups and harmonize procedures and processes.

· Develop and Maintain forecasting for Balancing test workload and test allocation across QC labs and testing sites (including CLOs) to maximize the utilization of QC resources, including oversight of CLOs and Partner communications

· Implement and Maintain Key Performance Indicator (KPI) and dashboards in SmartQC, etc. to assist the QC Leadership Team in detecting trends and areas of improvements for lab operations

Who You Are

Strong communication and presentation skills, both verbal and written, including ability to synthesize information for senior management Extraordinary attention to detail and ability to conduct and report analytic outputs with high level of precision

Qualifications

Required Skills

· Bachelors degree with 12+ years of direct experience

· Managing mid level managers, high level professional employees. Making & influencing decisions across the business & externally (eg: regulatory agencies, outcourced partners, etc...) Involvement with teams, organization on key issues, typically only as critical issues are escalated. Manages overall budget ($9-$15MM) and performance standards for organizations within department. Facilitates partnerships/contract laboratories, regulatory interactions; Influences External Leadership in longer term, higher visibility/high impact projects; Represents QC to Senior Management.

· Influence established within organization; Participating across Org/Site/Global Ext Leadership role in project interactions in a Matrix Role; Represents QC externally to stakeholders, customers, senior management and Global initiatives. Serves on Extended leadership team, SLT as appropriate. Oversight of site, global projects, understanding of impact and mitigation for project teams and site, global, quality directives. Little to no oversight from QLT, acts as an extension of management. Empowered to define own requirements/deliverables to meet final goals. Provides leadership for Site/Global.

· Accountable for successful delivery of team objectives across multi discipline teams at global/strategic level within budget; Decisions involve topics that are within & outside area of expertise; Leads more complex teams/ global projects. Supports & manages multiple complex problems/imperatives. Independently leads projects provides oversight, coaching to organizational members. Regularly contributes toward high risk/impact decision making; fosters team environment, values team over individual success consistently. Manages complex problem solving, providing mitigation/outcome to management/team. Clear, concise communication & leadership. Decisions include those that have potential high compliance impact to product, and/or Quality systems, decisions with impact to customers, or pertaining to personnel issues that must be handled with consultation & recommendations to HR/mgmt.  

Preferred Skills

• Strong analytical/critical thinking, communication and interpersonal skills.

• Experience in biotech/pharmaceutical operations or testing lab operations

• Strong quantitative abilities and problem solving skills

• Proficiency with LIMS, Oracle, Business Objects, Trackwise and Microsoft Excel

• Sound knowledge of cGMPs and equivalent regulations



Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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