Job Details

ID #11729748
State North Dakota
City Researchtrianglepark
Job type Full-time
Salary USD TBD TBD
Source Biogen
Showed 2021-04-02
Date 2021-03-28
Deadline 2021-05-27
Category Et cetera
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Head of Global Quality Control Operations

North Dakota, Researchtrianglepark 00000 Researchtrianglepark USA

Vacancy expired!

Job Description

The Head of Global Quality Control Operations is a key leadership role in the Pharmaceutical Operations & Technology (PO&T) organization, responsible for the development of a comprehensive strategy and implementation for Global QC testing of Raw Materials, Drug Substance, Drug Product and Finished Goods, as well as for building and operating global, high throughput QC laboratories as part of the PO&T division.

The position is both technical and strategic in nature. The Head of Global Quality Control Operations will be in charge of defining and developing Quality Control systems, covering all 4 modalities – small molecules, large molecules, gene therapy and ASOs, to improve efficiency, reliability, scale and overall cost of operations, to assure Biogen remains compliant with all US and international regulations with regard to GxP testing activities. This leader provides the highest level of GxP QC testing oversight and direction for internal and external testing programs supporting the PO&T organization. In addition, the role is accountable for informing Executive Management of potential business risks that may be incurred as a result of testing anomalies.

Managing a group of 300 people, this position is located in RTP, NC, reporting to Head of Global Quality.

MAIN RESPONSIBILITIES

Ensure Global Quality Control Operations operates within all US and International Regulations and Biogen Standards to ensure the purity, efficacy, and effectiveness of all Biogen Idec commercial and clinical drug supplies.

Responsible for review and approval of resources required to maintain sites in a state of compliance.

Establishes guidelines for appropriate distribution of resources across all sites to ensure that quality decisions can be made in a timely manner.

Lead and develop talent in Global Quality Control Operations organization which includes a team of Directors, Associate Directors and Managers who themselves are responsible for specific functions.

Responsible for development and implementation of strategy to improve efficiency and cost of laboratory operations as well as integration with manufacturing systems.

Responsible for the implementation of integrated quality control systems, policies, and standards at all Biogen U.S. and International testing sites.

Dictates short and long term strategies for QC operational systems and direction.

Establish clear goals and effective metrics that provide insight to industry benchmark and applicable trends with regard to Quality Control Operations. Participates in formulating and administering company policies. Directs and coordinates all activities to develop and implement long-range goals and objectives to meet business and profitability growth objectives.

Responsible for driving major projects and programs for Organizational Unit or Function to completion within schedule and budget. Typically manages multiple cost centers of a scope that require VP-level management.

Determines the development of overall objectives and long-range goals of the organization. Required to interact directly with senior representatives of regulatory agencies, including the FDA and EMEA.

Responsible for all strategy and oversight of Contracted Laboratory Operations to maintain GxP compliance and ensure timely QC testing. This oversight implies makingprincipal senior-level decisions on the acceptability of the compliance and operational conditions of all these operations and recommending action if standards are not being met. Provides direction to subordinates in more than one professional or scientific discipline.

Frequent and principal contact with outside suppliers, contract manufacturers, and senior levels within both PO&T and R&D organizations.

The incumbent is required to have the technical expertise to evaluate and challenge the data generated in a wide range of activities in order to assure that processes are robust. The Vice President must be a resource to his/her peers regarding continuous improvement, problem solving and strategic, as well as, tactical decisions within the Company.

Lead all continuous improvement initiatives. Reviews and approves projects related to operational excellence, system improvement, electronic enterprise systems, within Global Quality.

Qualifications

· Must have a minimum of 10 years of experience leading a Quality, Regulatory, or Corporate organization at the leadership level in a highly regulated environment, preferably in biotech, pharmaceutical or similar industry.

· Must have experience with the FDA, EMEA and preferably multiple additional regulatory agencies in other foreign countries.

· Experience in business Development, Sales, Manufacturing, etc. desirable.

· Thorough knowledge of FDA, EU and ROW regulations as they relate to both Quality Testing activities.

· Experience in clinical and commercial products as well as both large and small molecule programs

Quality and Compliance experience consistent with world-wide regulatory requirements.

· Experience with Quality Control Operations

Expert knowledge of US and International cGxPs

Ability to hire and retain top talent with a tack record of developing and leading “leaders”

Ability to influence the organization through consistent execution of Biogen leadership competencies

Strong leadership abilities required to effectively implement change management strategies

· Demonstrated strategic leadership through proactive engagement with the senior stakeholders, and through proactive communication at key meetings with PO&T leaders as well as external agencies.

· Ability to proactively formulate and communicate risk-based approaches to ongoing work. Willing to step up and confidently analyze the pros and cons and present recommendations.

· Strategic, able to see the big picture and consultative to client groups.

· Outstanding credibility and influence with senior executive leadership, executive peers, and other internal and external stakeholder groups, and communicate in a clear, concise, and effective manner.

· Demonstrated experience leading in a highly matrixed, dynamic global health care organization.

· An individual of unquestioned personal and business integrity who will be viewed as trustworthy both within the company and externally.

· Strong track record of outstanding decision-making abilities—able to make decisions logically, methodically, and quickly (as appropriate).

Education

MS, PhD preferred in pharmaceutical-related field.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Vacancy expired!

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