Supervisor, Quality Validation

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

The Validation Supervisor is responsible for planning and coordinating daily validation efforts for the qualification of pharmaceutical packaging, computer systems/applications, and, facility and utility systems/equipment. Each Validation Supervisor manages a team of 3 to 10 Validation Analysts, provides technical expertise and guidance to internal/external entities, and performs quality reviews of validation documents with the highest of quality standards.

• Coordinates validation efforts between the Validation, Operations, Engineering, Facilities Engineering, Information Technology, Maintenance, Business Unit, and Quality Assurance departments.
• Oversees and manages the team to conduct qualification and validation activities.
• Oversees team training, goal setting, and effective organizing and assigning of work.
• Reviews and approves quality validation documents including, but not limited to, statements, plans, protocols, test scripts, test results, temperature mapping, modifications, and deviations.
• Ensures completion, accuracy, and closure, including organizing and coordinating multiple approvals as required.
• Serves as validation expert to other departments, with customers, in meetings and conference calls.
• Participates in customer/regulatory audits, visits, and conference calls. Effectively communicates project goals and progress.
• Determines level of validation impact for product, software/hardware, and equipment changes, and reviews/approves change controls.
• Analyzes and resolves work problems, or assists staff in resolving work issues. Manages electronic time and attendance records.
• Initiates or suggests plans to motivate staff to achieve project deadlines. Suggests and implements changes to increase efficiency.
• Assists in matters of manpower planning, development, reward, and recognition.
• Assists in developing and maintaining department work instructions and job aids.
• Confers with Human Resources to resolve grievances.
• Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11, and Annex 11 policies, procedures, rules, and requirements.
• Attendance to work is an essential function of this position.
• May be required to complete and pass training courses such as "Documentation Boot Camp" and "Train the Trainer" as applicable.
• May be required to become primary contact as needed for validation activities and managing expectations.
• Performs other duties as assigned.

• Required:

  • Bachelor's Degree in a related field or 1-5 years of related experience and training.

  • College Level Mathematical Skills
  • Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
  • Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
  • Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.

  • High Standard of Report Writing

  Preferred:

  • Experience with quality validation documents including, but not limited to, statements, plans, protocols, test results, modifications, deviations, procedures, work instructions, and job aids.
  • Experience with computer systems, HVAC systems, and utilities.
  • Ability to work on multiple projects at the same time
  • Ability to meet aggressive timelines
  • Good interpersonal/teamwork skills
  • Effective communication skills (verbal and written form)

  #LI-SW1

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.