Director, Validation and Compliance

1 week ago

Macungie, Pennsylvania, United States Sharp Services Full time
Job Summary

The Director, Validation and Compliance will play a crucial role in leading the validation efforts associated with all GxP-related systems to ensure compliance with regulatory standards. This role requires a strong leader with excellent communication skills, capable of prioritizing and managing multiple projects effectively.

Key Responsibilities
  • Management and mentorship of the Validation department, including all aspects of the people process such as hiring, mentoring, coaching, annual objective setting, performance management, and employee development.
  • Maintain an understanding of cGMP, GEP (Good Engineering Practice), computerized systems validation, and guidance in relation to all aspects of validation across manufacturing and facilities.
  • Develop and implement strategies for equipment IQ/OQ/PQ, process validation, and computer system validation.
  • Plan, perform and coordinate validation projects to ensure timely completion.
  • Responsible for drafting and providing technical guidance for the validation program, Policies and SOPs and other master documents.
  • Support Engineering and Manufacturing in the development of critical process parameters and provide technical leadership for deviation investigations.
  • Perform functional and process risk assessments in conjunction with Quality and Manufacturing subject matter experts.
  • Provide clear recommendations to key stakeholders based on thorough analysis and best practice.
  • Ensure that the Quality Technical Transfer (QTT) team reviews and pre/post approves Qualification protocols, discrepancies, and associated reports in a timely manner reporting any concerns to Senior Management.
  • Interface with other departments such as Project Management, Engineering, Operations, Warehouse, IT, and Process Development to ensure that validation project plans are understood and in keeping with site objectives.
  • Represent the company as an SME for Validation, Data Integrity and Qualification compliance during regulatory inspections and partner audits, inclusive of support for the compilation of any required responses and other follow-up activities.
  • Provides updates to Senior Management on site validation activities status.
  • Provides validation training to staff on validation protocols and standard operating procedures.
  • Supports investigations and implementation of CAPAs, as needed.
  • Ensures the development of staff to assure competency (suitably qualified and experienced personnel) and support the achievement of objectives.
  • Support and encourage a "Quality Culture" and Sharp values.
  • Inspire and lead the team to meet department and site goals.
Requirements
  • Demonstrated knowledge and application of FDA cGMP/GCP regulations, ANSI/ISO/IEC/ASQC standards, and 21 CFR Part 11 in a manufacturing setting.
  • Demonstrated application of pFMEA, Risk Analysis, Validation principles, guidelines, and industry best practice.
  • Demonstrated history of team management and effecting cross-functional change with strong analytical problem-solving and interpersonal skills.
  • Excellent verbal and written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non-technical audience.
Preferred Qualifications
  • Prefer Bachelors, Masters, or Ph.D. in Biochemistry, Biology, or related science field.
  • A minimum of ten (10) years of experience working in an FDA-regulated environment in a functional role within validation, quality management, process controls, and/or continuous improvement. Of the ten (10) years of experience, at least five (5) years need to be in a validation role within the biotech/pharmaceutical industry.
  • Must have exceptionally strong communication, interpersonal and project management skills.
  • Ability to multi-task and methodically manage projects in a fast-paced manufacturing environment.
  • Ability to lead a team of validation associates to prioritize and manage multiple projects across several product lines.
  • Must be able to set expectations for the quality and timeliness of all deliverables.

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