SENIOR VALIDATION MANAGER
If you thrive in fast-paced, structured environments, if you're a driven self-starter, if you're seeking team engagement, then look no further. You'll work with one of the leading CDMOs in the world, with decades of experience and a track record of repeated organic growth and a long history of the development of state-of-the-art pharmaceuticals and medical devices. This institution specializes in treatments for diabetes, communicable diseases, cancers and many other illnesses, and distributes them to over 30 other countries. If you want to make a difference, start here.
You will head up daily operations for the Madison, WI Validation Team, including validation contractors, in support of 24/7 mfg. operations. You'll develop and carry out efficient validation strategies that meet all necessary regulatory requirements and industry standards. In partnership with validation leadership, you'll also manage all aspects of the site validation life cycle to oversee Facilities, Utilities, Equipment and Fill/Finish processes. In addition, you will ensure that changes in quality and regulatory compliance requirements are identified, documented, integrated, and maintained. Finally, you will support innovation, continuous improvement and synchronization of workflows, quality systems and procedural guidance around the validation of manufacturing processes.
- Ensure that the Madison site validation team meets production targets and stays within or under budget; that all products/procedures comply with cGMPs and corporate policies; that quality documents are complete and on time; that regulatory inspections are seen through to completion.
- Oversee validation team and approves GXP Assessments for Facilities, Utilities, Manufacturing Equipment, and components to define the collective requirements for validation. Support corporate Data Integrity and CSV initiatives.
- Direct and participate in validation protocol development, review, and approval; ensure that validation prerequisites have been properly conducted prior to validation execution.
- Ensure appropriate staffing of team with validation subject matter experts; assure that your team's competency remains concurrent with regulatory and industry standards.
- Interface with Regulatory agencies and clients, as required, in conjunction with new drug applications, Facility inspections, and technical interchanges to represent the company position with respect to validation. Perform deviations investigations in accordance with company and regulatory guidelines, and manage audits both internal and external.
- As a subject matter expert, represent these activities in discussions and communications with Client and regulatory agencies.
- Excellent written and oral communication skills.
- Demonstrated successful collaboration with multiple functions to coordinate the execution of validation activities and incorporate validation results into routine operational practices.
- Familiarity with regulatory requirements for validation, Aseptic Operations and Cleaning Validation.
- Prior experience authoring & executing process validation studies for commercial GMP manufacturing processes including process qualification (IOQ, PPQ, RQ) and managing the validation teams.
- Working knowledge of risk assessment methodologies and practices including prior experience using risk analysis for testing strategy development and justification.
- Proven track record of staff management, capable of developing people and teams with at least 10 years of management experience.
- Experience in successful management of complex Validation activities. Familiarity with Quality Management Systems and GxP Regulations.
- Sterile Fill Finish experience is highly desired. Process Validation experience a plus.
- Strong industry knowledge, project proficiency, and autonomy expected. Ideally a Subject Matter Expert in various disciplines. Prior manufacturing/Facility Startup and FDA PAI experience is preferred.
- Must possess in-depth knowledge of equipment, Sterile Fill/Finish process, CSV, Utilities, and cleaning validation.
- Hands on experience and knowledge of equipment such as Freeze Dryers, Washers, Tunnels, Sterile Filling, Autoclaves, Manufacturing/ Holding vessels, Incubators, CTUs etc.
- BS in Engineering or related Life Sciences with a minimum of (12+) years relevant experience or MS in related field with a minimum of 8+ years relevant experience preferably within a GMP manufacturing CMO (aseptic/sterile product facilities) environment or equivalent experience.
PHYSICAL REQUIREMENTS & MENTAL DEMANDS
- Must be able to stand for long periods of time each day.
- Travel to all company sites/facilities.
- Ability to successfully prioritize and multitask in an environment with competing demands and shifting priorities.
- Able to don ISO cleanroom gowning and PPE, as required by site procedures.