Director of Validation and Compliance

1 week ago

Macungie, Pennsylvania, United States Sharp Services Full time
Job Title: Director, Validation

Job Summary:

The Director, Validation will play a pivotal 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.

The successful candidate will be responsible for ensuring the highest standards of quality and compliance across our operations. They will oversee and lead the validation program for production equipment and processes used to support manufacturing activities at all Sharp US commercial packaging facilities.

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.
  • Represents 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.

Supervisory Responsibilities:

The Validation Managers from each US commercial site and the QTT Manager will report directly to the Director, Validation.

The candidate will be expected to carry out managerial responsibilities in accordance with Sharp's policies and applicable laws. Responsibilities include interviewing, hiring, training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Preferred/Required Education and/or Experience:

  • 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.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use hands to handle or write and to speak and hear. The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor and to perform tasks within close proximity to packaging equipment. The working environment is clean and not normally subject to hazardous environment or conditions.

Travel between Sharp US commercial sites as needed. Occasional travel to clients and/or vendors facilities.

This position can be based at any of the US commercial packaging sites and will be required to travel between sites on occasion. This is not a remote or hybrid position so the candidate is expected to be on site every workday.

Disclaimer:

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

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