QA IT Sr Specialist

Job Description

Position Overview:

The Sr. Specialist of Technology Quality Assurance will be responsible for the quality aspects of GMP computerized systems and the supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations.

This includes involvement in all quality-related activities for computerized systems which are required by the Quality Manual or with potential for impact on product quality, patient safety or data integrity.

The position will work closely with stakeholders and SME’s from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement.

The Sr. Specialist of Technology Quality Assurance must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.

Main Activities:

• Collaborating with stakeholders (e.g., System Owners, Process Owners, Data Owners and Technical Unit) to assess and select computerized systems which enable GMP business processes. This includes:
  • Ensuring Technologies selected meet the high-level business needs while encouraging innovation and efficiency.
  • Interfacing with Organon BT and other internal & external entities to align GMP shopfloor, laboratory, quality system and/or infrastructure technology capabilities/solutions with quality policies and objectives
  • Ensuring the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work.
• Providing the independent quality approval of key qualification /validation documentations such as policies, procedures, acceptance criteria, plans, protocols, requirements, reports and computerized system related changes to ensure compliance to company standards and applicable regulations throughout the computerized system lifecycle (including changes/modifications/deviations/variances/compliance investigations).
• Assuring site/above site system owners have Operating Level Procedures/Plans, approved by Quality, in place and routinely followed to ensure computerized system(s) remain in a validated status (e.g. problem and incident management, change control, periodic review, investigations, backup/restore, System Use and Administrative SOPs, disaster recovery plans, business continuity plans).
• Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective.
• Supporting regulatory inspection and audit activities as needed. This includes the review of audit or inspection reports, responding to findings related to IT applications, automated manufacturing equipment, automated lab systems and infrastructure (at local sites) and taking appropriate actions to ensure GMP compliance.
• Driving resolution of regulatory non-conformance for GMP computerized systems.
• Monitoring and communicating system health, compliance and other metrics updates to key stakeholders.
• Promoting GMP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices.
• Representing TQA management upon request in local site or system specific meetings regarding computerized systems selection, operation and/or compliance related issues
• Contribute to the development and maintenance of training programs in the principles of computerized systems validation and regulatory requirements in validation, maintenance and use of computerized systems.
• Mentoring, training and developing Specialist of TQA.

Qualification:

• Bachelor's degree: Pharmacist

Experience:

• Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations.
• At least two years of experience in delivering validated IT solutions or an application support role.
• Good understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211 and 820 and local regulatory expectations.
• Must demonstrate working knowledge of the principles, theories and concepts of computerized system validation / compliance.
• Familiarity or practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment.
• Limited supervision required in day-to-day activities.

Preferred Competencies and Skills:

• Operate as part of a self-directed team in carrying out day to day functions and assigning priorities
• Hands-on experience in a regulated pharmaceutical manufacturing and/or laboratory environment (Quality or Compliance role in GMP environment desired).
• Good understanding of applicable Laboratory and/ or Engineering Standards related to computerized systems development, implementation & Operations.
• Business engagement skills, with ability to collaborate with both technical and non-technical roles.
• Multi-lingual capabilities: fluency on English and Spanish
• Experience supporting regulatory inspections.
• Excellent oral and written communication skills including persuading others and developing cross functional relationships.
• Analytical problem-solving skills applied to issue identification and resolution.
• Listening, integrating diverse perspectives, adds value to the achievement of team goals.
• Timely decision making.
• Project management skills combined with a since of urgency and a proven history producing quality deliverables.
• Ability to respond to changing priorities.
• Inclusion behaviors.

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.

Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Salary Range

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R518723