Manager, GMP Operational Manager Analytical QA (Hybrid)
Boston, MA, United States
Manager, GMP Operational Manager Analytical QA (Hybrid) page is loaded Manager, GMP Operational Manager Analytical QA (Hybrid) Apply locations Boston, MA time type Full time posted on Posted 8 Days Ago job requisition id REQ-21755 Job Description
General Summary:
Th e Manager for Operational GMP QA is a technical resource in the principles and application of quality assurance and compliance . The Manager leads the coordination of GMP QA Analytical activities in support of release of Commercial Drug Product . The Manager coordinates and/ or executes activities on multiple complex projects and takes a role in the design and execution of new projects. The Manager adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with regulatory requirements. May manage and develop personnel to support department and functional activities. This role is a Hybrid Role and holds the requirement to be on site 3 days a week, with the option to work remotely 2 days per week.
Key Duties and Responsibilities:
Collaborates with internal and external business partners to resolve quality issues to ensure compliant solutions in support of QA Analytical function.
Responsible for oversight of analytical activities in support of release and validation activities for Commercial Drug Product (DP) . This includes analytical data review and COA generation and approval.
Participates in cross-functional teams as an experienced Quality technical resource .
Assists Change Control owners with ensuring compliance with regulatory and procedural requirements . Assesses and approves change controls for implementation and closure.
Guides and conducts quality investigations /OOS investigations, deviations and reviews corrective action plans for adequacy and compliance.
Lead s root-cause analysis and product impact assessment .
Ensures appropriate CAPA actions are identified and addressed. Approves investigations/CAPAs.
Responsible of QA oversight of analytical methods’ qualification and transfer, ensuring compliance.
Collects, maintains , and reports Quality Metrics .
Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed .
Work with supplie r s to ensure inspection readiness.
Identif ies , facilitate s , and/or lead s continuous improvement efforts.
Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and method reports .
Identif ies and communicate s risks and assist s with risk mitigation plans as necessary .
Provides support for audit or regulatory inspections , a ssists in preparation of audit response s, as needed .
May manage personnel and provide oversight of day-to-day operations.
May a ssists with workforce planning/resource modeling and to update through forecasting activities .
Knowledge and Skills:
Good understanding of both the conceptual and practical application of cGMPs in a pharmaceutical setting . Understanding of global GMP requirements and support of GMP manufacturing and testing.
Demonstrated ability to evaluate quality matters and solve problems leveraging technical experience and advanced judgement to select appropriate solutions .
Strong communication skills (written and verbal) with the ability to effectively communicate with cross functional team members, exchanging complex information and influencing/guiding others to understand a stated viewpoint .
Proven experience to plan an d manage workload to achieve goals . A bility to work in a fast-paced environment and meet quality, accuracy and timeliness objectives .
Strong experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA .
Strong e xperience with electronic quality management systems .
Strong knowledge of analytical techniques (such as HPLC, GC, KF, etc.,).
Strong team communication skills with the
Experience using project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks .
E xperience leading complex projects/teams and continuous improvement initiatives within stated objectives and timelines .
Education and Experience:
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
Operational QA experience in analytical or manufacturing setting, interpretation, and application of GMPs and applicable guidelines/guidance’s ex . ICH , USP, etc.
Advance knowledge of GMP regulations , regulatory requirements and applicability to duties.
Hybrid-Eligible Roles
In this Hybrid-Eligible role, you can choose to be designated as:
Hybrid: work remotely up to two days per week; or select
On-Site : work five days per week on-site with ad hoc flexibility.
#LI-Hybrid
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected].
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Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency .
Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook , Twitter/X , LinkedIn , YouTube and Instagram .
The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives.
Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
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