Intuitive Technology Solutions is currently recruiting for a Senior Manager, Quality Processes and Analytics to join the team of a global pharmaceutical company located in Jacksonville, FL.
Resolves and manages technical and tactical operational problems.
- Responsible for the strategy, implementation, and oversight for the Vision Care Process Validation, Change Management, SPC and Quality Analytics teams.
- Ensure the appropriate standards and guidelines are in place for the validation program in order to support the design, construction, commissioning, validation and validation maintenance of facilities, equipment, systems, methods and processes.
- Direct the validation approach and strategy to ensure continuous improvement that is consistent with established and evolving regulatory requirements and corporate requirements.
- Ensure that validation programs, procedures and practices are compliant with corporate and applicable government medical device regulations including FDA QSR, Japan rPAL, and ISO 13485.
- Serve as the partner to top management by providing validation oversight and counsel.
- Provide professional leadership in the development and communication of validation strategies.
- Oversee companywide validation programs and provide guidance and expertise to project teams for all validations.
- Develop and continuously improve the validation program to enhance effectiveness, efficiency and compliance.
- Establish key performance metrics for validation to improve efficiency through process improvements and utilization of resources.
- Review process documentation for confirmation that all qualification and/or validation activities are consistent with regulatory and quality requirements.
- Responsible for global Engineering Change Control process and procedures.
- Ensure changes are value added, justified, appropriately reviewed, assessed and tested to ensure no negative product impact and that changes are properly documented in the quality system.
- Responsible for oversight of the QA and Analytics group.
- Provide reporting and statistical support to the business; be responsible for the implementation and oversight of Statistical Process Control in manufacturing.
- Develop the infrastructure, control and reaction plans for adequate implementation and/or oversight. Adhere to environmental and safety policies and procedures and support the safety and environmental objectives of the department.
- Defines complex issues; recommends and guides implementation of functional strategies; manages departmental/projects day-to-day operations within area of responsibility.
- Spokesperson for functional area. Technical expert for functional area; makes the complex clear and compelling; conceptual knowledge of all responsible functions and business areas.
- Represents the department/project in providing solutions to difficult technical issues.
Mentors and facilitates successful team behavior within and across functional area and typically serves in a project leadership role.
- Establishes key operating practices for department/project and functional area, ensuring cross-functional synergy. Drives innovation within functional area.
- Develops and implements functional area initiatives to delivery customer value at lowest cost.
Holds people accountable for measurable results.
- Manages relationships externally and internally for functional area.
- Builds cross-functional and cross-departmental support. Fosters overall group effectiveness.
- Provides coaching, useful feedback, and direction to direct reports/teams.
- Ensures and measure improvement for development of staff.
- Identifies high potential candidates. Fosters harmony within functional and other areas.
- Promotes the business value of diverse perspectives. Influences and persuades to bring about process and technical improvements.
A minimum of a Bachelor’s Degree is required.
A minimum of a Bachelor’s Degree in an Engineering or Computer Science discipline is preferred.
An MBA or other Advanced Degree is preferred.
A minimum of eight (8) years of quality and compliance experience in the Medical Device and or Pharmaceutical industry is required.
A minimum of twelve (12) years of quality and compliance experience in the Medical Device and or Pharmaceutical industry is preferred.
A minimum of eight (8) years of work experience in Process Validation and Change Control within the Medical Device and/or Pharmaceutical industry for new products or existing products is required.
Prior experience leading regulatory audits is required.
Prior experience implementing Statistical Process Control programs is required.
Prior experience with global health authorities and agencies is preferred.
Prior experience in new product development or R&D is preferred.
Demonstrated skills in cost / time estimation, scheduling, project management, negotiation, and delegation are required.
Strategic and visionary leadership skills with a focus on customer service and implementation of global solutions is required.
An excellent understanding and application of principles, concepts and practices of Process Validation, Commissioning & Qualification (C&Q), Risk Management, Engineering Change Control, SPC, Root Cause Analysis / Failure Investigation, and the QSR / ISO Regulations is required.
Master Black Belt training or certification is preferred.
Strong leadership and coaching skills are required and prior experience leading a team of quality professionals is preferred.
This position may require up to 25% domestic and international travel and will be based in Jacksonville, Florida.
About Intuitive Technology Solutions:
Intuitive Technology Solutions is a comprehensive provider of staffing and workforce solutions throughout the Scientific Industry, including Biotechnology, Pharmaceutical, Clinical Research, Healthcare, Biodefense, Environmental, Chemical and Food Sciences. We are actively seeking candidates for contract, contract-to-hire and permanent placement jobs throughout the nation. View our website to see a list of our current open positions; however, not all of our positions are listed so don’t forget to submit your resume and request a consultation with one of our scientific recruiting specialists to explore your opportunities further.
At Intuitive Technology Solutions we understand that next to your family, your career is one of the most important aspects to a happy and fulfilling life. This is why we take the time to truly understand and get to know our candidates, so we can then pair them with the right job, not just any job. As a result, Intuitive Technology Solutions is known throughout the industry for quality, reliability and the highest satisfaction from both our clients as well as the candidates that we represent. Intuitive Technology Solutions is an equal opportunity employer .