Product Quality Director, CMC Small Molecule QA

Vertex Pharmaceuticals Inc (US); Boston (MA); Hybrid; USD 176,000 - 264,000; Full time

Job summary

A leading global biotechnology company seeks a Product Quality Director to oversee quality strategies for small molecule and biologics. The role involves ensuring compliance with cGMP and regulatory standards, collaborating across functions, and managing quality throughout the product lifecycle. Candidates should possess extensive experience in quality assurance, drug development, and leadership in a pharmaceutical setting.

Benefits

Annual bonus

Generous paid time off

Educational assistance programs

401(k) matching

Commuting subsidy

Qualifications

• Minimum of 10 years in a technical/quality/regulatory role in pharmaceuticals.
• Key areas of expertise include DS/DP manufacturing and regulatory submission authoring.
• 5 years in managing staff and leading cross-functional teams preferred.

Responsibilities

• Accountable for end-to-end quality oversight throughout the product lifecycle.
• Develop and maintain critical Quality standards and control requirements.
• Proactively identify Quality risks and support post-approval changes.

Skills

cGMP compliance

FDA guidelines

Quality Assurance

Project Management

Risk Management

Strategic thinking

Education

Bachelor's or Master's degree in a Scientific/Technical/Business discipline

Job description

Product Quality Director, CMC Small Molecule QA page is loaded

Product Quality Director, CMC Small Molecule QA

Apply locations Boston, MA time type Full time posted on Posted 12 Days Ago job requisition id REQ-24958

Job Description

The Product Quality Director is accountable for end-to-end quality oversight of small molecule, biologics, or device program(s) throughout clinical development, commercialization, filing, approval, launch, and post approval lifecycle management activities. This oversight includes setting and maintaining overall Quality strategies in support of commercialization efforts including establishing relevant product quality standards for current or novel technologies (including devices where applicable), ensuring QA and cross-functional alignment with industry and regulatory expectations, identifying product quality risks and mitigations throughout the development lifecycle of the assigned program, through commercialization and decommissioning. The candidate should have a good understanding of drug development and commercialization and be able to partner effectively with development functions (i.e., process development, analytical development, manufacturing science and technology, site QA/QC, and regulatory CMC) and commercial functions (i.e., AS&T, MS&T, QC, QA Operations, Supply Chain) to enable a robust product development (Quality by Design -QbD) approach that considers technical, regulatory, and quality / compliance considerations per cGMP regulation. The candidate will ensure a robust supply chain and support product launch activities per program needs.

The candidate will foster strong collaboration and partnership with external and internal stakeholders, and the international Quality leadership team. This individual will provide strategic guidance and direction to the integrated benchmarking and external environmental monitoring for identifying emerging industry trends and best practices to facilitate maximum value to evaluation of the health of the quality system.

Key Duties & Responsibilities

• Provide clearly defined Quality expectations, Quality strategy, and Quality deliverables for the assigned program(s) within the Vertex product portfolio, including in-licensed and outsourced products, as part of commercialization and product lifecycle management.
• Develop, approve, and maintain critical Quality standards and control requirements for products and processes (e.g., stage gate deliverables, product specifications, stability program development), working in collaboration with key internal and external stakeholders, embedding the principles of product lifecycle and QbD. Ensure quality and compliance frameworks, guidance, and systems are in place to keep them current with general industry and health authority expectations as well as Vertex’s QMS.
• Critically evaluate new products and processes with respect to Quality and compliance requirements. Work with development functions and supply chain to improve manufacturing processes, new product introduction standards, and overall program strategy and keep them current with global regulatory expectations and internal Vertex standards, integrating the scientific intent of the technical SMEs and clinical phase-appropriate approaches, as applicable.
• Proactively identify Quality risks and improvement opportunities for the assigned program(s) across all stages of manufacturing and across all drug product presentations in support of commercialization. Ensure that the identified risks, mitigations, and possible improvements are understood by CMC development team stakeholders by working with project teams and stakeholders to mitigate them during clinical development, validation, submission, and launch.
• During lifecycle management of a product, support post-approval changes due to continuous improvement, regulatory requirements or commitments, geo-expansion strategy, and business driven reasons. Proactively identify Quality risks and product quality issues and support post-approval changes to mitigate these risks by partnering with the commercial manufacturing project teams and stakeholders.
• Ensure significant Quality risks are escalated per the company procedure and properly mitigated in a timely manner by working with the cross-functional/site teams.
• Champion a consistent approach to Quality and compliance standards as they relate to product, recognizing the wider implications of Quality-related issues, including the implementation of the principles of Quality by Design and new and emerging regulatory guidance.
• May serve as a single point of Quality contact for new product introduction and PAI readiness for the assigned product(s) on the CMC product and/or project governance teams covering Analytical Development, Process Development, Technical Operations, and Supply Chain topics for GMP/GDP clinical trial materials and commercial products to ensure a global Quality strategy is developed and maintained for consistency and standardization (to the extent it is practical).
• Represent Quality at appropriate governance meetings to critically review product strategy, promoting a risk-based approach.
• Act as a project manager within Quality for the assigned project, ensuring and facilitating effective multi-directional communication between the Quality groups and cross-functional teams and ensuring standardized processes (e.g., new product introduction, risk assessments, technology transfers, etc.) are used.
• Support preparation of CMC clinical and commercial regulatory submissions by critically reviewing and approving relevant documents per team timeline and associated HA questions on the filing. Support device development for combination products (as needed) by taking part in design history file reviews, strategy, risk identification, and risk mitigation.
• Define resource allocation for network of QA resource assignment for his/her/their assigned products.

Education and Experience

• Bachelor’s or Master's degree in a Scientific/Technical/Business discipline.
• Minimum of 10 years of deep and broad experience in a technical, quality, and/or regulatory role within the pharmaceutical/biopharmaceutical industry in product development and associated project management and governance is required.
• Key areas of preferred expertise are: DS/DP manufacturing, process validation, specification setting, control strategy setting, regulatory submission authoring.
• A minimum of 5 years in directly managing staff and/or leadership experience in leading cross-functional teams, projects, programs, or directing allocation of resources is preferred. Previous experience on a Site Leadership Team or R&D Leadership Team is strongly preferred.

Required Knowledge/Skills

• Expertise in cGMP compliance, FDA guidelines, and international guidelines dealing with pharmaceutical manufacturing and Quality Assurance, quality standards, policies and procedures.
• Demonstrated application of the principles of cGMP and Quality Assurance.
• Experience in the practicalities of implementing 21st century cGMP guidelines, ICH Q8/9/10/11, PAT/ASTM guidance, etc. In-depth understanding of quality processes/systems (e.g., change control, event handling, CAPA), risk management and manufacturing control strategies.
• Direct experience with regulators (e.g., NDA, BLA, MAA submissions and/or inspections).
• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member.
• Demonstrated influential leadership experienced in operating in a matrix organization (across boundaries) with Technical, Supply Chain and Regulatory functional areas through presenting, influencing, negotiation and partnering is required. Capable of building alignment across diverse perspectives and functional areas.
• Demonstrated strategic thinking capability with strong project management skills and ability to focus on execution of strategic decisions
• Experience in technology transfer, process development and/or process validation.

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Pay Range:

$176,000 - $264,000

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.

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]

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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.