Manager, GMP Operational Analytical Quality (Hybrid)

Vertex Inc.•Boston, MA

3d•Hybrid

About The Position

The Quality Manager is an advanced technical resource in the principles and application of quality assurance and compliance. The Quality Manager coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects. The Quality Manager adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements. Quality Manager provides quality oversight and sets strategy for process validation, cleaning validation, method validation, and/or product stability activities Demonstrates appropriate quality oversight of root-cause analysis and product impact for product quality investigations, ensuring appropriate CAPA actions are identified and addressed. Approves investigation/CAPA’s Reviews trend reports for product quality events (deviations, OOS, product complaints, CAPA) and ensures appropriate implementation plans are identified and completed for CAPA’s Provides strategies to address compliance gaps or determines enhancements to cross-functional quality systems. In addition to Quality Lead Responsibilities: Provides quality oversight and sets strategy for process validation, cleaning validation, method validation, and/or product stability activities Demonstrates appropriate quality oversight of root-cause analysis and product impact for product quality investigations, ensuring appropriate CAPA actions are identified and addressed. Approves investigation/CAPA’s Reviews trend reports for product quality events (deviations, OOS, product complaints, CAPA) and ensures appropriate implementation plans are identified and completed for CAPA’s Provides strategies to address compliance gaps or determines enhancements to cross-functional quality systems

Requirements

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.
Experience leading complex projects/teams and continuous improvement initiatives within stated objectives and timelines; effectively apply 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 able to influence others to understand a point of view and gain alignment around a proposed action.
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 take 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).
Bachelor's degree in scientific or allied health field (or equivalent degree)
Typically requires 4 years of experience, or the equivalent combination of education and experience
Experience in Analytical Laboratory with experience in Bioanalytical, Wet and Solid State Chemistry
Operational QA experience in analytical and/or manufacturing setting, interpretation, and application of cGMPs and applicable guidelines/guidance’s (example: ICH, USP)
RCA tools/methodology/ technical writing
Lean Six Sigma Training
Facilitation/ problem solving /organizational, planning

Responsibilities

Proven experience leading and managing complex projects/teams within corporate objectives and project timelines
Displays ability to effectively influence others within technical area of expertise
Possesses the ability to apply technical knowledge beyond own specialty area within a global context
Assists with project planning and provides input on design and methodology development
Recognized as a mentor with strong abilities to transfer technical knowledge and teach analytical skills to junior staff
Possess the ability to apply phase appropriate decisions in development and commercial space
Clearly demonstrates effective communication skills (written and verbal) with the ability to transcend organizational levels
Fosters the demonstration of the Vertex Core Values and leadership behaviors in others
Integrates activities with those of other groups, departments, and project teams as needed
May oversee the technical functions and coordinate the activities of a group or small team with a common discrete technical focus or discipline
May supervise other staff members, motivate personnel and resolve conflict
May provide information to assist in budgeting, scheduling, and performance requirements
Demonstrated competence in a supervisory role if directly managing others
Helps craft individual goal setting to best pursuit of corporate and department goals if managing staff
Performs other duties as assigned
Supports GMP Quality management for product disposition activities as needed
Develops and/or maintains quality systems to support of manufacture, and testing in GMP QC laboratories; includes writing or reviewing/approving SOPs
Supports equipment validation, calibration activities, and preventive maintenance programs
Provides oversight and approval of investigations, deviations, and performs quality metrics trending for the laboratory areas as required
Leads and/or supports investigations for GMP QC laboratory issues, such as deviations and OOS
Performs equipment qualification/validation, as necessary, including writing protocols, executing qualification/validation, and report writing
Provides other quality support and oversight as requested by GMP QC Laboratories and Analytical Development