Senior Specialist Quality Assurance

Job Description

Role Summary:

The Sr. Specialist Digital and Data Quality 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 our manufacturing division's 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 DDQ must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.

Essential Functions and Responsibilities :

The Senior Specialist -Digital & Data Quality is responsible for:

As part of the Global Digital & Data Quality team, the Senior Specialist collaborates with stakeholders (e.g., System Owners, Process Owners, Data Owners, Business Unit, Technical Units and Subject Matter Experts) to assess and remediate legacy systems and evaluate / implement new computerized systems, which enable GxP business processes. This includes:

• •Ensuring Technologies selected meet the high-level business needs while encouraging innovation and efficiency.
• •Interfacing with Corporate Global IT and other internal & external entities to align GxP 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 documentation such as policies, procedures, acceptance criteria, plans, protocols, specifications, 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 at-site/above-site system owners have Operating Level Procedures/Plans in place, and are routinely followed to ensure that 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 (including sufficiently detailed electronic data review/audit trail review instructions for users), 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 site) and taking appropriate actions to ensure GxP compliance.
• •Driving resolution of regulatory non-conformance for GxP computerized systems.
• •Assuring monitoring of system health, compliance and other metrics are communicated to key stakeholders.
• •Promoting GxP 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 Digital & Data Quality management upon request in local site or system specific meetings regarding computerized systems selection, operation and/or compliance related issues.
• •Contributing to the development and/or maintenance of training programs in the principles of computerized systems validation, computer software assurance, and regulatory requirements in validation, data integrity, ALCOA principles, maintenance, and use of computerized systems.
• •Providing Quality Unit review/approval of SDLC documentation.
• •Mentor and provide guidance to junior members of the team.

Qualification:

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

Required 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.
• •At least 3 years of experience in delivering validated IT solutions or an application support role in a regulated environment.
• •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 to collaborate with both technical and non-technical roles.
• •Multi-lingual capabilities preferred
• •Experience in leading conversation during regulatory inspections
• •Excellent oral and written communication skills including persuading others and developing cross functional relationships both at site and across sites
• •Analytical Problem-solving skills applied to issue identification and resolution
• •Listening, integrating 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
• •Coach and develop others #EBRG #VetJobs

Required Skills:

Active Listening, Active Listening, Adaptability, cGMP Regulations, Change Management, Coaching, Computer System Validation (CSV), Data Integrity, Data Quality, Deviation Management, GMP Compliance, GMP Documentation, GMP Guidelines, GMP Validation, Good Automated Manufacturing Practice (GAMP), Government Regulation, Information Technology (IT), Manufacturing Quality Control, Peer Mentoring, Pharmaceutical Quality Assurance, Prioritization, Problem Analysis, Problem Identification, Procedure Adherence, Product Disposition {+ 15 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For mor