Sr Mgr. QA Global Quality Agreements
Anywhere, NY, USA | Gilead Sciences
Industry:Pharmaceutical / Biotech
Job Description:64 people have viewed this job
Sr Manager, QA Compliance – Global Quality Agreement Program
Quality Assurance delivers on Gilead’s commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies.
As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.
You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining QA within PDM, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Meet the worldwide QA Team: https://qualityassurance-careers.gilead.com/
The Sr. Manager, QA Compliance will report to the Director, QA Compliance – Global Quality Agreement Program within the Global Quality Systems & Compliance (GQSC) department. This position is dedicated to support the Gilead Global Quality Agreement Program. This position will have high visibility and will collaborate with key internal partners/stakeholders to establish and maintain effective and timely Quality (Technical) Agreements (QAGs) with various GMP-related relationship types and support program related initiatives.
- Responsible for managing the entire QAG life-cycle process (processing requests, reviewing, drafting, negotiating, routing for approvals/signatures, archiving, amending/revising, conducting periodic reviews, and retiring) for QAGs with Contract Manufacturing Organizations (CMOs), Contract Testing Laboratories (CTLs), GMP Materials Suppliers, GMP Services Providers, Strategic Clinical Collaboration Partners, Commercial Marketing Partners, as well as for Intra-Company GMP activities, in accordance with applicable GMP regulations and Gilead policies, procedures and practices. Perform risk assessment of proposed terms/quality provisions in QAGs and develop recommendations to minimize their potential risk to the business
- Develops negotiation strategies with and ensure the completion of applicable reviews of QAGs by key stakeholders (Gilead personnel from Quality (Clinical/Commercial), Production/Operations, Outsourcing Management, Supply Chain Management, Business Operations Contract Compliance (BOCC), Alliance Management, Legal/Contracts and/or other applicable Subject Matter Experts), obtaining leadership approvals, as required, to ensure Gilead position is operationally correct and accurately reflected in the QAG. Ensures the QAG is in alignment and not conflicting with the primary, business agreement
- Coordinates meetings with external parties (e.g.: CMOs, CTLs, GMP Material Suppliers, GMP Services Providers) and internal stakeholders/SMEs and facilitates the review and negotiation of QAGs
- Coordinates systems and procedures related to processing of QAGs; prepares/assembles the final QAG package for authorized approval signatures and publishing in global electronic QAG life-cycle management system / repository
- Assists with the administration and maintenance of the Global QAG database/trackers to reflect real time data/status; assists with the generation and preparation of QAG/Program metrics / status reports and presentations to Senior Leadership
- Responds to requests and inquiries related to QAGs (content/statuses, etc.) from internal stakeholders
- Responsible for assisting with the implementation of the Global Quality Agreement Program initiatives (governance, oversight, processes and services) by collaborating cross-functionally and geographically with key stakeholders
- Assists in the development and implementation of policies, standards, SOPs, work instruction/job aids for the management of QAGs and compliance monitoring thereof
- Creates training materials and conducts training related to QAGs, the Global QAG Program and its systems and tools
- Collaborates with key stakeholders to develop standardized, fit-for-purpose QAG Templates; Manages the review, approval, issuance, revision and retirement of QAG Templates
- Provides global QAG Program systems and processes support to GQSC QAG team and participates in system and process improvements and remediation (perform gap assessments and participate in development and execution of remediation strategies
- Other duties as required or assigned by Director to meet business needs
Assigns, monitors and reviews progress and accuracy of work for an individual, a group of employees, or a project. Follows up on questions from assigned departments. Leads by example to foster a commitment to quality in personnel, and a culture of quality within the organization. Assists with maintaining standard of quality for compliance department operations. Assists in regulatory agency inspections. Interacts and influences peers to ensure successful project completion. Maintains current knowledge of Compliance program and of applicable company standard operating procedures for areas of responsibility. Provides guidance on interpretation and application of specified QA compliance regulations. Assists in the evaluation and implementation of standard operating procedures and systems needed to comply with requirements.
Knowledge, Experience & Skills:
- Demonstrates excellent organization skills and ability to work on a number of projects to tight timelines.
- Demonstrates excellent attention to detail, and ability to consistently meet high standards of quality required in QA Compliance.
- Resourcing Excellence
- Internal Use Only
- Demonstrates excellent verbal, written, and interpersonal skills.
- Capable of taking a leadership role in updating and preparing the company for minor changes in regulations.
Specific Education & Experience Requirements:
- 8+ years of relevant experience in the pharmaceutical industry and a BS or BA.
- 6+ years of relevant experience and a MS
- Demonstrates expertise with quality agreements for both domestic and international GMP regulations and/or extensive contracting (contract drafting/negotiating) experience in the pharmaceutical/biopharmaceutical industry
- Demonstrates excellent influencing, negotiation, and technical / business writing skills
- Excellent project management skills / experience
- Demonstrates the ability to incorporate sound Risk Management fundamentals in the establishment of quality agreement content
- Demonstrates excellent technical/business/legal writing skills; must have strong document or contract management skills (word processing/formatting)
- Excellent working knowledge of computer systems/applications; i.e. Microsoft Word, Excel, Pivot tables, Visio, Gantt Charts, and PowerPoint
- In-depth experience with electronic document control management or electronic contract life-cycle management systems (e.g.: Documentum, Veeva Quality Docs, Apttus, Ariba, or other electronic document control/contract life-cycle management systems)
- Strategic and technical knowledge for managing global quality agreement processes for various types of service providers
- Supplier management or audit management experience
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