Sunovion Executive Director, Clinical & PV Quality Assurance in Marlborough, Massachusetts

Job Description:

The incumbent will provide strong leadership and strategic direction to the Sunovion Quality Assurance teams responsible for Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GVP) and Computer System Validation (CSV) compliance. The incumbent will possess significant expertise in leading a quality team responsible for oversight of all phases of the product development life cycle, including pre-clinical, clinical and post-marketed Pharmacovigilance. The Executive Director, Clinical and PV QA will partner with key leaders within Sunovion R&D such as Clinical Operations and PVRM to ensure that Sunovion clinical trials and PV activities are conducted according to applicable regulatory standards and Sunovion quality standards. He/she will also provide quality oversight of the validation of GXP regulated systems according to regulatory requirements. The Executive Director, Clinical and PV QA will be a key contributor to the Global Quality Management System, leading and/or participating in a variety of global projects with DSP and other subsidiary companies.

Job ID: 6280BR

Department: QA/QC

Location: Marlborough, MA

Job Type: Full-time

Summary of Responsibilities: The incumbent will provide strong leadership and strategic direction to the Sunovion Quality Assurance teams responsible for Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GVP) and Computer System Validation (CSV) compliance. The incumbent will possess significant expertise in leading a quality team responsible for oversight of all phases of the product development life cycle, including pre-clinical, clinical and post-marketed Pharmacovigilance. The Executive Director, Clinical and PV QA will partner with key leaders within Sunovion R&D such as Clinical Operations and PVRM to ensure that Sunovion clinical trials and PV activities are conducted according to applicable regulatory standards and Sunovion quality standards. He/she will also provide quality oversight of the validation of GXP regulated systems according to regulatory requirements. The Executive Director, Clinical and PV QA will be a key contributor to the Global Quality Management System, leading and/or participating in a variety of global projects with DSP and other subsidiary companies.

Essential Functions: The Executive Director, Clinical and PV QA will:

•Develop an organizational structure aligned with current and future business and quality objectives.

•Manage the department budget and headcount to support company objectives.

•Drive the achievement of Quality objectives through leadership of direct reports, while overseeing GCP, GLP, GVP and CSV regulated processes throughout the business.

•Establish and maintain a Quality Management System that supports GLP, GCP, GVP and CSV compliance including Quality Polices, SOP’s and WI’s.

•Implement robust Sunovion and global risk-based audit programs to ensure ongoing compliance to applicable regulations.

•Ensure the development and implementation of appropriate CAPA’s

•Lead the Sunovion inspection readiness program for areas of responsibility including training, mock audits, SME preparation and inspection management. Play a key role in interactions with regulators before, during and following inspections. Ensures implementation of effective CAPA’s to prevent recurrence.

•Provide quality oversight of the computer system validation function through approval

of validation strategy, document approval, change management and audit.

Lead and/or participate on global and cross-functional teams to maintain and improve the Global Quality Management System, representing his/her areas of responsibility.

•Present quality data and metrics at Regional and Global Management Review meetings.

•Advise senior management of critical quality and compliance related issues. Develop corrective actions to mitigate quality and compliance risks.

Minimum Education Requirements: Bachelors

Experience Required: 10+ Years

Knowledge & Skills (General and Technical): •Degree in sciences or pharmaceutics with an MS or above preferred

•15 years or more of experience in GCP, GLP and GVP quality roles in a FDA-regulated biotechnology, pharmaceutical or medical device company.

•10 years of progressive leadership of a department or team responsible for GCP/GLP/GVP quality

•Comprehensive knowledge of international regulatory requirements and guidelines governing GCP,

GLP, GVP and CSV

Other Requirements (Licenses, Certifications, Specialized Training, Physical or Mental Abilities Required): •Previous successful interactions with FDA, MHRA and/or EMA required

•Track record of resolving complex quality and compliance issues internally and externally

•Previous experience managing in a global, matrixed quality environment is preferred

•Excellent interpersonal and communication skills with the ability to collaborate effectively with peers and leadership across several disciplines.

•Experience working with CROs under a strategic partnership relationship is preferred

•Proactive quality compliance while optimizing operational efficiencies

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best" industry practices and the highest ethical standards.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a computer for extended periods of time.

Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer

Sunovion is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.