Team Lead (Work from home)

Do you want to be part of an inclusive team that works to develop innovative therapies for patients Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. We are a leading pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world.

We recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. Hybrid work from certain locations may be permitted in accordance with the Responsible Flexibility Guidelines.

Responsible for managing and executing the Technology and Data Quality Assurance (TDQA) audit and validation oversight programs related to regional Digital X processes for computer systems, technology solutions, clinical and commercial systems, data integrity processes, and related process improvement initiatives within QA.

Provides operational management to drive consistent cGxP compliance and validation approaches to ensure compliance with standards, policies, and procedures.

Ensures compliance with global Electronic Records / Electronic signatures regulations and related cGxP regulatory requirements.

Responsible for managing the TDQA audit program related to audits of vendors, service providers, and internal processes in support of computerized system validations for new system implementations, system upgrades, change controls, and periodic reviews for computer systems.

Develops, facilitates, and implements process improvements and supports new technology initiatives as continually invests in new technology solutions and computerized systems.

Contributes to the development, implementation, and successful execution of the QA mission, objectives and 3-5 year strategic plan.

Responsible for directing and executing the TDQA program to oversee the computerized systems validation program, clinical, commercial, and R&D electronic systems.

Performs and ensures issue resolution, audits, and regulatory authority inspection preparation.

Facilitates and leads the development and implementation of related continuous process improvement programs within Information Technology and business departments.

Develops and drives the implementation of quality strategies and tactics related to Electronic Systems, technology solutions, and overall Quality discipline that ensure long term success for the quality assurance function. Translates strategies into prioritized short- and long-term objectives for the TDQA and QA department.

Leads initiatives and programs across multiple departments, regions, business functions, and internal/external partners. Establishes and prioritizes quality initiatives to ensure execution of multiple projects concurrently.

Responsible for the overall management of QA oversight of IT processes, electronic systems, technology solutions, and validation projects to assure quality of output as well as compliance with standards, policies, procedures, and regulations. Presents and defends validation strategy during Regulatory Authority and 3rd Party Inspections. Utilizes risk-based approaches to process oversight.

Directs the establishment and execution of internal and vendor audit program related to computer software providers and computer related service providers utilized.

Develops and drives the implementation of policies, procedures, standards, and tools in support of validation processes, data integrity processes, and quality systems and interfaces across multiple departments and levels of management. Authors, reviews, and approves departmental Quality System Documents as necessary. Participates in the biennial review of Quality System documentation.

Ensures inspection readiness for regulatory inspections, 3rd Party inspections and internal audits.

Provides leadership to functional areas with minimal management oversight. Provides guidance to functional areas across for validation, and quality systems related consultations. Represents QA management on process improvement project teams to provide regulatory compliance and technical expertise in all areas of continuous improvement, innovation, and validation.

Manages the development and utilization of tools to track, trend and report quality metrics to management to assure that systems and procedures comply with external regulatory authority requirements for compliance. Collects and shares metrics to facilitate the Management Review process.

Minimum of 7 years in the pharmaceutical industry, with a minimum of 3 years in a Quality Assurance role.

Demonstrated leadership skills, including the ability to lead and manage projects and staff in a matrixed, global setting.

Demonstrated knowledge of global industry standards and regulatory requirements for, software development, computer system validation, Electronic Records / Electronic Signatures regulations, Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP), and related GxP regulations in the global regulatory environment including GAMP5, 21 CFR Part 11, EU Annex 11, and Japan Notice 0401022.

Comprehensive knowledge of quality assurance of computer system validation process management in a pharmaceutical manufacturing and clinical development environment.

Demonstrated knowledge of development, management, and execution of internal and vendor auditing processes, audit reporting systems, and audit/CAPA management.

Demonstrated experience in facilitating and supporting regulatory agency inspections and third party audits pertaining to Data Integrity and Electronic Records/Electronic Signatures compliance with successful outcomes.

Demonstrated experience facilitating and leading global process improvement and harmonization activities, especially in the areas of Data Integrity, computing environment development, validation, control, and maintenance.

Demonstrated competence to resolve complex and diverse problems with decision making responsibility that has a major impact within Quality and/or with functional groups globally.

Effective written and oral communication and interpersonal skills, facilitation and influencing skills with an ability to interface globally across multiple departments and across various levels of management and with external stakeholders.

Domestic and international travel of 5-10% is required.

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Category Quality Systems

EOE including Disability/Protected Veterans