Manager, global quality tech ops-digital transformation & innovation

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.

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• System Maintenance: Serve as a global technical lead for MasterControl configuration enhancements to standardize ways of working, deployment of new modules, and system integrations with PCI’s Enterprise Resource Planning system and other potential systems.
• Metrics & Analytics: Design, build, and maintain automated quality metrics dashboards (e.g., via PowerBI or MasterControl Insights) to track KPIs, CAPA trends, and training compliance.
• Validation & Compliance: Collaborate on validation life cycle documentation (URS, FRS, IQ/OQ/PQ) adhering to GAMP 5 methodologies, FDA 21 CFR Part 11, and Annex 11.
• Process Digitalization: Translate traditional paper-based or hybrid quality workflows into streamlined, automated digital workflows within MasterControl.
• Data Integrity: Establish and enforce data integrity governance across digital platforms to satisfy FDA, EMA, and MHRA expectations.

This position may require extra hours 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.

Supervisory Responsibilities:

Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

No Supervisory Responsibilities.

Special 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. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

• Stationary Position: 3/4 of the day and up.
• Move, Traverse: None.
• Operate, activate, use, prepare, inspect, or place: None.
• Install, place, adjust, apply, measure, use, or signal: None.
• Ascend/Descend or Work Atop: None.
• Position self (to) or Move (about or to): None.
• Communicate or exchange information: From 1/4 to 1/2 of the day.
• Detect, distinguish, or determine: From 1/4 to 1/2 of the day.
• On an average day, the individual can expect to move and/or transport up to 10 pounds less than 1/4 of the day.

This position may have the following special vision requirements.

• Close Vision ☐
• Distance Vision ☐
• Color Vision ☐
• Peripheral Vision ☐
• Depth Perception
• Ability to focus ☒
• No Special Vision Requirements

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.

The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

Work is primarily performed at a desk and/or in an office environment for 3/4 of the day and up.

The noise level in the work environment is typically quiet.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Bachelor's Degree in a related field and/or 5-7 years related experience and/or 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.
• 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.

Preferred:

• Ability to work independently and/or as part of a team.
• Strong proficiency in data visualization tools (PowerBI, Tableau) or SQL.
• Experience managing data migration activities from legacy systems to cloud-based QMS platforms.
• Excellent communication skills to translate complex technical requirements to non-technical quality stakeholders.

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, Equity and Inclusion 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.