Digital Quality and Data Integrity Lead (Relocation Available)

Job Responsibilities

• Review and approve life cycle documentation, Change Controls, Validation Plans, URS, FRS, etc.

• Responsible for providing Digital Quality (dQ) support for Deviations and CAPAs associated with Computerized and Software Systems.

• Responsible for presenting and defending dQ and Data Integrity (DI) programs and associated verification artifacts at client audits and regulatory inspections.

• Leads dQ and DI initiatives at the site.

• Leads and works with site cross-functional team to assist in establishing alignment, harmonization, and standardization with corporate-wide Digital Systems Governance Programs (such as SDLC, Data Integrity, Risk Management, Periodic Reviews and others).

Act as a Data Integrity steward, responsible to:

• Drive the assessment and risk management and remediation strategy and execution plan for Data Integrity controls (including testing) of digital systems procured by and/or designed/developed in-house at Resilience; collaborate with site stakeholders and central DI program lead to institutionalizing on-site.

• Define appropriate DI controls as part of purchasing and implementing equipment/systems and processes.

• Ensure site Quality and compliance of GxP activities with respect to internal and/or customer procedures as well as FDA, ICH, EU, and country-specific regulations

• Serves as a liaison between site functions (including Tech Ops, business QC/QA, and Validation) and the central dQ and Data Integrity functions.

• Lead/assist/oversee Digital System / Vendor audits per established risk-based strategy at the site level.

• Lead/conduct/oversee training of Resilience personnel on Electronic Records (21CFR11), CSV, Data Integrity, and relevant Quality SOPs at the site level.

• Represent site Digital Quality at site quality leadership, site Quality Review Board and the central dQ/DI and Governance boards to enable the adoption of corporate dQ and Data Integrity standards.

• Assists in the development systems strategy that pilots and implements efficient, cutting-edge technology on new platforms, including intelligent robotic automation solutions utilizing artificial intelligence (AI) and machine learning (ML) technologies at the site and central functions.

• Always maintain systems in a state of inspection readiness.

• Assess and advise SMEs on maintaining systems in a state of inspection readiness.

• Establish and report to site leadership and corporate leadership on site-based dQ/DI KPIs.

• Assist in internal audits, customer audits, and regulatory inspections.

• Recruits talent (contract and/or full-time) as appropriate and builds a high-performance team; mentors and coaches' personnel.

Physical Requirements:

This job requires the employee to perform the following physical activities:

* Use of fingers

* Stooping

* Kneeling

* Repetitive motion

* Standing

* Grasping

* Walking

* Hearing

* Pulling

* Lifting

* Talking

This job requires the employee to work in the following conditions:

* Activities occur inside and outside

This job requires exposure to the following:

* Noise (enough noise to cause the employee to shout to be heard above ambient noise level.)

* Hazards: moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals).

* Hazards: packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.

* Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.

* Conditions that affect the respiratory system or the skin: fumes, odors, dust, mists, gases, or poor ventilation.

* Narrow aisles or passageways.

This job requires the employee to perform the following type of physical work:

* Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

* Light work.Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.

This job requires the following visual acuity requirements:

* Preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.

This job requires routine or periodic use of respiratory protection:

* Loose-fitting respirators, such as hood or helmet-style Personal Air Purifying Respirators (PAPR).