Head, Site Quality
Our client is a global biotechnology company. They have asked us to assist them in their search for a Head, Site Quality
Major tasks and responsibilities will include:
We seek candidates with the following qualifications
- Provides Manufacturing, Quality Control and Engineering Oversight including issue and Risk Management.
- Collaborates with internal partners in order to facilitate compliant and successful manufacturing.
- Provides round the clock Quality Assurance support to the Value Streams.
- Works closely with all functions to proactively identify and mitigate Quality issues and concerns.
- Ensures adherence to deviation management and change control procedures/policies.
- Ensures that the pharmaceutical intermediates and/or products released are manufactured and tested in accordance with GMP and any relevant regulations, applicable specifications and regulatory filings.
- Oversees site self-inspection processes.
- Spearheads site-wide Quality Management Reviews, ensuring appropriate actions and escalations.
- Collaborates with Enterprise Head of Compliance to implement enterprise wide compliance processes.
- Leads the Site Quality Leadership team to develop cross-functional working relationships, foster collaboration and develop the Site-based Quality community.
- Serves as the primary point of contact for Quality as it relates to regulatory inquiries or inspections.
- Collaborate with business partners including quality leaders, site leadership, supply chain leadership and others to identify improvement opportunities across the organization.
- Leads efforts to automate processes and procedures to reduce errors and improve product quality.
- Works with operations leaders and team members to define the implementation strategies for continuous improvement across the organization.
- Develops appropriate tools and methods to sustain improvements across the organization.
- Supports the development and implementation of global processes and procedures consistent with regulatory requirements and corporate standards.
- Holds accountability for quality oversight at the site ensuring compliance with regulations in all relevant markets.
- Serves as a leader and provides guidance to a site-based Quality Assurance team.
- Sets objectives and provide clear direction for execution.
- Holds responsibility for organizational design and staffing decisions.
- Recruits, retains, trains and develops the Operational Quality team.
- Requires a Master’s degree in the life sciences field. PhD highly preferred.
- Must have a minimum of 12 years of experience in the pharmaceutical industry in roles with increasing responsibility in quality management.
- Must have a minimum of 8 years of experience in a managerial position
- Requires significant first-hand GMP management experience.
- Experience directly executing a QA function and system within a manufacturing context is required.
- Requires experience working in a highly regulated manufacturing environment.
- Experience leading, training and/or implementing root cause analysis and effective investigation practices.
- LEAN experience is highly preferred.
- The proven ability to build, mentor and grow a high performing team is required.
- Must have the demonstrated ability to influence at all organizational levels through clear, concise and impactful verbal and written communication skills.
- Requires substantial knowledge of cGMP’s, FDA, TGA, EU and other relevant GxP regulations.
- Knowledge of auditing practices and procedures is required.
If interested, please apply directly to this job posting. 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.