QA IT Site Ops

**THE OPPORTUNITY**:
The Sr. Specialist Digital & Data Quality (DDQ) 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.

**WHAT YOU WILL DO**:
The Sr. Specialist DDQ must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.

As part of the global DDQ team and reporting to the Associate Director of DDQ or higher, the Sr. Specialist DDQ will be responsible for:
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 our site manufacturing IT and other internal & external entities to align GMP shop-floor, 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 documentation 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.

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 DDQ management upon request in local site or system specific meetings regarding computerized systems selection, operation and/or compliance related issues.

Contribute in 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 DDQ Specialist.

WHAT YOU MUST HAVE

**Qualification**:
Bachelor's degree. Preferably in Science, Information Technology, Engineering or equivalent.

**Experience**:
Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations.

Min 5 years of experience in regulated pharmaceutical manufacturing industry.

Strong 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 extensive knowledge of the principles, theories and concepts of computerized system validation / compliance.

Familiarity and 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**:
Professional Certifications (e.g. Six Sigma or certification in Project Management (PMP)

Operate as part of a self-directed team in carrying out day to day functions and assigning priorities

Good understanding of applicable Engineering and/or Laboratory or Standards related to computerized systems development, implementation & Operations

Hands on experience in a Quality and/or Compliance role in a GMP environment

Business engagement skills, with ability t