Director, QA For Pharmacovigilance & Risk Management

Location
Marlborough, MA
Posted
Nov 02, 2018
Discipline
Quality, Quality Control
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time

Establishes and maintains the Global Quality System for Pharmacovigilance and Risk Management (PVRM) that supports Sunovion regional and DSP global products in compliance with ICH Guidelines and international regulatory requirements. Develops and maintains policies and procedures for the PVRM Quality System and provides Quality Assurance support for SOP’s, auditing, deviations, training and CAPA. Leads the establishment and execution of a global risk-based PVRM audit program for DSP Companies, contract vendors and third parties working closely with quality counterparts globally. Leads inspection readiness and management activities for Sunovion and coordinates global inspection readiness activities for PV inspections of global products. Collaborates with global PVRM and quality staff as well as QPPV to ensure global coordination of quality system activities. Monitors the global and regional PVRM Quality System through metrics and reports on the status of the Quality Systems to Head of Global Quality and Head of Global PVRM.

Essential Functions

 

• Establishes and maintains a comprehensive global Quality System for global products ensuring compliance with international regulatory requirements for PVRM activities. Ensures that global and regional documents comply with international regulatory requirements.
• Establishes and maintains a global PVRM audit schedule of DSP Companies and contract vendors that provide PV services aligned with regulatory requirements. Ensures adherence to annual and long-term audit schedule and development of comprehensive CAPA plans to address audit findings. Tracks completion of audit CAPA’s. 
• Conducts PV audits of vendors and third parties in global territories and provides oversight for consultants conducting audits on behalf of the Company. Coordinates the development and maintenance of appropriate contracts (MSA, SOW, CDAs) for all consultants as required.
• Develops a program to manage deviations and CAPA arising from PVRM activities conducted at DSP Companies or at third party contractors/vendors. Ensures appropriate investigation of deviation events and development of CAPA plans and provides QA approval of Quality System documents. Ensures tracking of deviations and CAPA through completion. 
• Leads inspection readiness activities for Sunovion PVRM (US) and manages FDA inspections and responses. Coordinates inspection readiness efforts for global products and participates in inspection readiness/management activities at DSP Companies and at third party vendors. 
• Works closely with PVRM staff and QPPV to ensure compliance to EU PVRM requirements by providing Quality System data related to the PVRM. 
• Plays a lead role in Global PV Audit team and works closely with Quality counterparts that support PVRM at DSP Companies.
• Represents Quality at Global and regional PVRM Meetings and provides quality guidance on quality related topics.
• Provide periodic reports/assessments to Quality and PVRM Management on the compliance status of PV Quality systems.
• Monitor and assess overall compliance trends and issues for PV systems and processes and provide periodic assessments and trend reporting to management

Minimum education requirements

Bachelors

Experience required

7 - 10 Years

Knowledge & skills (general and technical)

Education

Minimum of Bachelor’s degree in a scientific discipline (e.g. biology, chemistry, pharmacy) or relevant field of study; or equivalent combination of training and experience in a regulated industry.

Experience

  • Must have a minimum of 8+ years’ experience in a regulated biotechnology, pharmaceutical, or medical device company, with a minimum of five years’ experience in PV- related role. 
  • Previous experience in auditing PVRM systems and or contractors/vendors required.
  • Expert knowledge of ICH, GCP, GPvP, US and EU regulations, industry standards and best practices for PV is required. 
  • Previous experience in a global QA environment supporting the PV function is preferred.
  • Experience in interactions with regulatory inspectors is preferred.
  • Must be a hands-on technical professional with a comprehensive understanding of current FDA regulations, and pharmaceutical industry quality standards as well as international expectations for quality systems. 


Complexity

Must have good understanding of PV and quality regulations and pharmaceutical industry quality standards. Must be able to interpret and apply regulations to internal procedures and practices, investigate compliance issues, and make/evaluate proposals for solutions.

Must be able to travel internationally periodically for PV audits, global PVRM meetings and/or regulatory inspections.

Personal Contacts

• All levels within Sunovion Pharmaceuticals Inc. and counterparts at DSP Companies 
• Management levels at contract organizations.

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.