Head, Quality and Compliance
Company Name:
Geneva Pharmaceuticals/Sandoz
# Job Description
The Head of Quality and Compliance within the Novartis Institutes for BioMedical Research (NIBR) is a newly created role that will become the central architect and coordinator of a comprehensive quality strategy and quality system for NIBR as a whole.
This role will be expected to:
Initially to work with NIBR senior management and line function heads to define an overarching quality strategy, quality culture and quality system that is applicable to the wide range of research activities that occur within NIBR. With this in hand, structure/build the group necessary to execute on the agreed upon strategy
As necessary, review and recommend changes to activities that currently fall within the formal GxP quality areas and are currently operating under Novartis Corporate QA oversight and guided by the established quality systems for these areas
Review and recommend quality standards within a comprehensive quality system for the non-GxP regulated areas within NIBR
Importantly, once a quality system is endorsed for the GxP regulated areas, ensure that there is an appropriately documented description of that quality system such as quality modules, etc.
Establish, execute and maintain a communication and training program to ensure that all associates understand the quality system and how it applies to them
Establish and/or maintain systems to ensure compliance with the quality standards. This includes mechanisms to formally track compliance, monitor effectiveness of the quality system relative to its objectives
Act as the primary liaison between NIBR management and Corporate QA while maintaining an overarching perspective of quality and compliance across NIBR
# Minimum requirements
This is a senior, instrumental role within NIBR requiring a unique background and perspective on quality within a diverse research organization. The qualified candidate must have extensive experience working within well-defined quality systems. Specific experience in GxP Quality Assurance is required. Specific experience in a non-GxP Quality System would be a significant advantage. Ability to interact across all levels of the organization along with demonstrated success in a matrix type role is required.
To be considered, a candidate must have a Ph.D. in the life sciences with at least 10 years of experience or an M.S. with at least 15 years of experience within the pharmaceutical industry. Highly experienced candidates with backgrounds in the legal profession, manufacturing or clinical development roles will also be welcome.
Other attributes considered core are strong strategic vision, superior leadership, excellent communication, consensus building, well developed influencing and negotiation skills. A clear sense of personal accountability, an ability to empower people, and a high degree of mutual respect and integrity are essential factors to succeed. Demonstrated ability to work globally and effectuate change within the company. The candidate will be required to travel internationally. In addition to a demonstrated and required fluency, both written and oral, in English, additional language skills in German, French and/or Chinese are considered to be a plus.
Job ID: 124854BR
Posting Title: Head, Quality and Compliance
Division: Novartis Institutes for BioMedical Research (NIBR)
Business Unit: CFO
Country: USA
Work Location: Cambridge, MA
Company/Legal Entity: USA Novartis Institutes for BioMedical Research, Inc., Cambridge, MA
Functional Area: Research
Job Type: Full Time
Employment Type: RegularEstimated Salary: $20 to $28 per hour based on qualifications.
Geneva Pharmaceuticals/Sandoz
# Job Description
The Head of Quality and Compliance within the Novartis Institutes for BioMedical Research (NIBR) is a newly created role that will become the central architect and coordinator of a comprehensive quality strategy and quality system for NIBR as a whole.
This role will be expected to:
Initially to work with NIBR senior management and line function heads to define an overarching quality strategy, quality culture and quality system that is applicable to the wide range of research activities that occur within NIBR. With this in hand, structure/build the group necessary to execute on the agreed upon strategy
As necessary, review and recommend changes to activities that currently fall within the formal GxP quality areas and are currently operating under Novartis Corporate QA oversight and guided by the established quality systems for these areas
Review and recommend quality standards within a comprehensive quality system for the non-GxP regulated areas within NIBR
Importantly, once a quality system is endorsed for the GxP regulated areas, ensure that there is an appropriately documented description of that quality system such as quality modules, etc.
Establish, execute and maintain a communication and training program to ensure that all associates understand the quality system and how it applies to them
Establish and/or maintain systems to ensure compliance with the quality standards. This includes mechanisms to formally track compliance, monitor effectiveness of the quality system relative to its objectives
Act as the primary liaison between NIBR management and Corporate QA while maintaining an overarching perspective of quality and compliance across NIBR
# Minimum requirements
This is a senior, instrumental role within NIBR requiring a unique background and perspective on quality within a diverse research organization. The qualified candidate must have extensive experience working within well-defined quality systems. Specific experience in GxP Quality Assurance is required. Specific experience in a non-GxP Quality System would be a significant advantage. Ability to interact across all levels of the organization along with demonstrated success in a matrix type role is required.
To be considered, a candidate must have a Ph.D. in the life sciences with at least 10 years of experience or an M.S. with at least 15 years of experience within the pharmaceutical industry. Highly experienced candidates with backgrounds in the legal profession, manufacturing or clinical development roles will also be welcome.
Other attributes considered core are strong strategic vision, superior leadership, excellent communication, consensus building, well developed influencing and negotiation skills. A clear sense of personal accountability, an ability to empower people, and a high degree of mutual respect and integrity are essential factors to succeed. Demonstrated ability to work globally and effectuate change within the company. The candidate will be required to travel internationally. In addition to a demonstrated and required fluency, both written and oral, in English, additional language skills in German, French and/or Chinese are considered to be a plus.
Job ID: 124854BR
Posting Title: Head, Quality and Compliance
Division: Novartis Institutes for BioMedical Research (NIBR)
Business Unit: CFO
Country: USA
Work Location: Cambridge, MA
Company/Legal Entity: USA Novartis Institutes for BioMedical Research, Inc., Cambridge, MA
Functional Area: Research
Job Type: Full Time
Employment Type: RegularEstimated Salary: $20 to $28 per hour based on qualifications.
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