Vice President, Quality Systems & Compliance
Our client is a leading global biotech company. They have asked us to assist them in their search for a Vice President, Quality Systems & Compliance
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Manages, directs and maintains the company’s Quality Management System (QMS), quality oversight of GxP computerized systems, global internal audit, company-wide Risk Management processes and supplier quality management.
- Establishes and maintains a standardized QMS.
- Sustains and improves this system when required.
- Establishes and oversees the global quality policies, standards and procedures for computerized systems.
- Ensures regulatory compliance of all internal GxP functions and external GxP vendors.
- Works with an emphasis on the simplification and standardization of the company’s QMS and SOPs in an effort to improve compliance and efficiency.
- Assesses, redesigns and implements the company’s QMS to meet global GxP compliance requirements, industry standards and business needs.
- Ensures implementation of the QMS across the network.
- Develops and implements quality risk management tools and principles to improve quality, compliance and GxP decision making.
- Stays abreast and communicates regulatory inspection trends, new regulations and the latest regulatory guidance (i.e. combination products, data integrity, etc.) and coordinate global implementation plans.
- Executes the quality supplier management program.
- Creates, maintains and executes the company’s quality supplier management program.
- Sets the strategy, standards, global processes and procedures for supplier introduction, qualification and approval.
- Facilitates root cause analysis and corrective actions of supplier quality issues and supports through his/her team on-site supplier visits for root cause analysis and verification of correction actions of supplier quality issues.
- Collates and evaluates supplier quality data to identify process improvement opportunities within the supply chain.
- Works with the supplier directly, create corrective action plans to address quality failures and issues.
- Develops and reports on supplier quality Key Performance.
- Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or system.
- Facilitates the Executive Quality Management Review for senior management including preparations, actions and escalations.
- Prepares materials for Audit and Risk Management Committee and Corporate Annual Report.
- Develops and leads a cohesive team of senior Quality leaders responsible for consistent standards, systems and quality culture across the company.
- Implements efficient and standardized organizational structures for Quality Systems across the network.
- Responsible for the Quality talent development and succession planning.
- Coaches and serves as a mentor key talent.
- Sets and delivers Quality budgets and targets for Quality Systems & Compliance.
- Key member and influencer in the company’s Quality Leadership Team.
- Collaborates with senior leaders in all areas of Quality to achieve standardized systems and compliance across all parts of the operation.
- Bachelor’s degree in biological, medical, or pharmaceutical sciences or related field required.
- Advanced degree highly preferred.
- Must have a minimum of 15 years of experience in the pharmaceutical industry.
- Must have a minimum of 10 years of managerial experience
- Requires demonstrated experience in roles of increasing responsibility in quality or operations management.
- Requires experience in preparing and complying with required regulatory guidelines including inspection readiness and follow-up.
- Extensive history of dialogue and discussion with regulatory health authorities required.
- Must be skilled at Quality risk-based decision making with the ability to transfer these skills into team.
- Requires a solid background in driving out inefficiencies and implementing standardized processes across large networks.
- The demonstrated ability to influence all organizational levels through clear, concise and impactful verbal and written communication skills is required.
- Must have the ability to build, mentor and grow a high performing and cohesive team of senior Quality Leaders.
- The ability to work across a range of countries and cultures is required.
- Requires experience with the implementation of a standardized practices across a network.
If interested, please email your resume as a Word attachment to us. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.