Senior Manager, GMP Operational Quality

Job Description

The Senior Quality Manager is an advanced technical resource in the principles and application of quality assurance and compliance. The Senior Quality Manager coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements.

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• Provides Quality oversight and support of external manufacturing CMOs and performs batch disposition activities.
• Collaborate with internal and external business partners to ensure an appropriate level of service is being provided to Vertex and to resolve complex quality issues to ensure compliant solutions.
• Participates in cross-functional teams as an experienced Quality technical resource responsible for providing quality oversight and support to manufacturing operations at contracted suppliers.
• Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex.
• Measures CMO performance and provides feedback when needed.
• Assists Change Control owners with ensuring compliance to change procedure requirements.
• Assesses and approves change controls, may also serve as Change Owner for Quality.
• Conducts quality investigations /deviations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations, OOS, and complaints.
• Ensures appropriate CAPA actions are identified and addressed.
• Approves investigations/CAPAs.
• Identify, facilitate, and/or lead continuous improvement efforts.
• Maintains Quality Metrics to support process improvement activities.
• Provides tactics to address compliance gaps or recommends enhancements to cross-functional quality systems.
• Conducts GMP document review, including procedures, work instructions, specifications, protocols, and reports.
• Responsible for coordinating, facilitating and follow up on any QLT action items assigned.
• Identifies and communicates risks and assists with risk mitigation plans as necessary.
• Supports internal audit or external audit programs.
• Assists in preparation of audit responses.
• Manages audit CAPAs & metrics.
• Provides technical advice for partner and regulatory agency audits.
• Provides information to assist in budgeting and scheduling.

Minimum qualifications:

Knowledge and Skills:

• In-depth knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and support of GMP manufacturing.
• Strong team leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy and timeliness objectives.
• In-depth experience leading complex projects/teams and continuous improvement initiatives within stated objectives and timelines; effectively applies project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks.
• Ability to independently lead cross-functional teams and represent the Quality unit.
• Ability to mentor and guide staff, skilled at transferring technical knowledge and teaching quality management skills.
• Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex and sensitive information and is able to influence others to understand a point of view and gain alignment around a proposed action.
• Demonstrated ability to manage teams and to develop personnel.
• Demonstrated ability to work independently to provide QA advice for large, multifaceted projects.
• Demonstrated ability to evaluate quality matters and make complex decisions leveraging technical experience, advanced judgement, and the analysis/synthesis of a variety of information; able to work outside of precedent and takes a new perspective on existing solutions.
• Strong experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA.
• Strong experience with electronic document management systems (e.g., Veeva).

Education and Experience:

• Bachelor’s degree in a scientific or allied health field with 6+ years of relevant work experience, or the equivalent combination of education and experience.
• Experience providing Quality support and oversight of GMP manufacturing operation including batch release.
• Experience with drug substance, spray dried dispersion (SDD) and drug product (oral solid dosage forms preferred) development and manufacturing with proficient know