GMP Operational Quality Senior Specialist

Vertex Pharmaceuticals Inc (US); United States; Ibrido; USD 94.000 - 141.000; Tempo pieno

Descrizione del lavoro

Vertex Pharmaceuticals Inc (US) is seeking a GMP Operational Quality Senior Specialist to support QA and regulatory compliance. You will assist with investigations, CAPA actions, change controls, and quality agreements while collaborating across functions to drive improvements.

Ideal candidates will have a scientific or allied health degree and about 2 years of related experience in a GMP/pharma environment, with strong communication and problem-solving skills to ensure timely, compliant

Competenze

• Bachelor's degree in a scientific or allied health field; typically 2 years of experience or equivalent mix of education and experience.
• Experience supporting investigations and quality improvement in a GMP/pharmaceutical setting.

Mansioni

• Support quality oversight for root-cause analysis and product impact assessments for investigations (deviations, OOS, OOT) and CAPA actions.
• Support change control assessments, implementation and closure.
• Identify and facilitate continuous improvement efforts.
• Assist in drafting/revising Quality Agreements between CMOs/Suppliers and Vertex.
• Represent Vertex Quality on cross-functional teams with strong communication.
• Support ongoing continuous improvement projects.

Conoscenze

Root Cause Analysis

CAPA

Cross-functional collaboration

Quality investigations

cGMP knowledge

Strong communication

Formazione

Bachelor's degree in scientific or allied health field

Descrizione del lavoro

Job Description General Summary: The GMP Operational Quality Senior Specialist supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities, and supports new/existing project initiatives.

Key Duties and Responsibilities

• Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.
• Supports change control assessments, implementation and closure
• Identifies and facilitates continuous improvement efforts
• Supports drafting and revising Quality Agreements between CMOs/Suppliers and Vertex, as needed
• Helps represents Vertex Quality on cross-functional working teams, applying strong communication and collaboration skills.
• Support continuous improvement projects

Knowledge and Skills

• Experience supporting multiple projects/teams within stated objectives and timelines
• Experience supporting cross-functional team members and collaborate effectively
• Good communication skills (written and verbal) and the ability to exchange potentially complex information
• Able to integrates activities with other groups, departments and project teams as needed
• Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent
• Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives
• Expanded conceptual knowledge of cGMP's in a pharmaceutical setting
• Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA

Education and Experience

Bachelor's degree in scientific or allied health field (or equivalent degree) Typically requires 2 years of experience, or the equivalent combination of education and experience

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range

$94,200 - $141,200

Disclosure Statement

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status

In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

#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 [e-mail]

Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. 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 IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters 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 17 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 LinkedIn, Facebook, Instagram, YouTube, and X We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.