Director, 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.

Summary of Objective:

The Director of Validation is responsible for oversight of all validation and calibration efforts and functions at PCI Pharma Services. Major responsibilities include the establishment and maintenance of PCI Pharma's validation strategy, policies and Master Validation Plan (MVP), as well as direct oversight of the Validation and Calibration Department and all associated programs and related activities. The Director of Validation will drive standardization across PCI Pharma Services as a site leader in the Validation Center of Excellence (CoE), and serve as the subject matter technical and process expert on global harmonization efforts with other PCI Pharma facilities. This position will serve as the public-facing Validation Subject Matter Expert (SME), and assure that customer requirements, cGMP requirements, and all foreign and domestic regulations are accurately incorporated into PCI's Validation programs.

Essential Duties & Responsibilities:

• Participate in the PCI Global Validation Harmonization efforts to drive harmonization of processes across PCI's facilities.
• Manage the PCI Rockford Calibration Program including review/approval of related procedures and identification of areas for improvement in streamlining the calibration department processes.
• Develop, improve, and maintain standards for calibration and validation best practices and training.
• Provides strategy and leadership for validation staff to conduct qualification and validation activities for process, equipment, utilities, and computer systems. Direct and manage efficient utilization of staff resources in order to meet project goals and timelines.
• Develop validation line management and staff, with a focus on continuous organizational development. Oversee proper training, goal setting and effective organizing and assigning of work.
• Reviews and approves validation and change control documentation, including protocols, summary reports, etc., for validation activities, process parameters, and validation work practices.
• Direct strategy on validation efforts for validation programs that is in compliance with regulatory and customer expectations, which includes developing and maintaining Master Validation Plan and associated policy and work practices.
• Design, maintain and continually improving the validation system in line with current national and international standards. Serve as the public-facing Validation Subject Matter Expert (SME) for PCI Pharma validation activities.
• Serve as Validation Subject Matter Expert (SME) for external customers, regulatory and trade agencies. Provide guidance to the groups within the organization and customers on validation policies and procedures and the implementation of those within the Production and Quality Control (QC) functional areas.
• Develops and manage validation department budgets, schedules and performance requirements and evaluations.
• Ensures validation representation on cross-functional and multi-site teams to support integrating risk management into various product quality systems such as Change Control and CAPA.
• Participates, present and provide rationale for the validation program during periodic audits and regulatory inspection and customer visits/conference calls as required.
• Participate in Operational Excellence projects as necessary.
• This position may require overtime and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance to work is an essential function of this position
• Performs other duties as assigned by Manager/Supervisor.

Qualifications:

• Bachelor's Degree in a related field and/or 5-7 years related experience and/or training.
• Statistical and Advanced 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.
• Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables.
• Ability to Travel
• High Standard of Report Writing

Preferred:

• Ability to effectively present information to various people as the job requires.
• Ability to identify and resolve problems in a timely manner.
• Ability to display original thinking and creativity.
• Ability to show success in managing employees.
• Ability to demonstrate attention to detail.
• Ability to set and achieve challenging goals.

The base salary hiring range for this position is ($143,000 - $170,000) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).

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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.