Quality manager jobs in Wakefield, MA - 674 jobs

Vice President, Global Quality Assurance and Regulatory Affairs page is loaded## Vice President, Global Quality Assurance and Regulatory Affairslocations: Boston, MA, UStime type: Full timeposted on: Posted 2 Days Agojob requisition id: R10077We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice.## Job DetailsWe are seeking a dynamic and experienced **Vice President of Global Quality Assurance and Regulatory Affairs** to lead our global QA/RA organization. This executive will be responsible for shaping and executing the company's quality and regulatory strategy, ensuring compliance with global standards, and driving continuous improvement across the product lifecycle. This is a critical leadership role that partners closely with R&D, Operations, Marketing, and Commercial teams to enable innovation while maintaining the highest standards of quality and compliance. **The role is based in our Boston Global HQ at 125 Summer Street and requires approx. 25% travel to our global locations.****Key Responsibilities*** Lead and oversee the global QA and RA organization, ensuring compliance with FDA, ISO, AABB, and other regulatory requirements across all geographies.* Serve as a liaison with regulatory bodies, including the FDA, and manage all compliance-related interactions.* Develop and implement robust quality assurance programs, policies, and processes to ensure product performance and customer satisfaction.* Drive global regulatory strategies for new product submissions, pre-market notifications, and lifecycle management.* Provide leadership and vision for quality objectives aligned with Haemonetics' business goals.* Advise senior leadership on compliance issues and readiness for inspections; lead corrective actions and continuous improvement initiatives.* Direct worldwide QA/RA staff, including organizational design, talent development, and performance management.* Monitor trends, complaints, and deviations to identify opportunities for improvement and report findings to leadership.* Represent QA/RA in strategic business decisions, including clinical study design and regulatory approvals.* Prepare and manage short- and long-term plans and budgets for the QA/RA function.* Occasionally present updates to the Board of Directors on quality and compliance matters.* Acts as Management Representative having authority that includes:* Ensures that processes needed for the quality management system are established, implemented, and maintained.* Reports to leadership on the performance of the quality management system and any need for improvement.* Ensures the promotion of awareness of quality and customer requirements throughout the organization.* Ensures that all organizational activities and operations are implemented in accordance with the highest ethical standards and are carried out in compliance with company policies and local, state, federal, and international regulations and laws.**Qualifications :****Education:*** Bachelor's degree in a scientific, business, healthcare, or technical discipline (required). Master's degree (preferred).**Experience:*** Min. 10 years of direct management experience in QA/RA for the design and production of medical products* Min. 10 years of experience operating within FDA-regulated cGMP manufacturing environments, including successful FDA interactions and product submissions.* Experience managing global teams* Proven success in managing regulatory affairs functions* Experience in quality systems management for medical devices**Skills:*** Exceptional verbal and written communication skills.* Strong stakeholder management and influencing capabilities.* Effective leadership and team-building skills.* Ability to manage complexity and lead diverse global teams.* Critical thinking and strategic partnership skills.## **Pay Transparency:**The base pay actually offered to the successful candidate will take into account, without limitation, the candidate's location, education, job-knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics' employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company's long-term incentive plan, with eligibility and target amount dependent on the role.In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, “flexible time off” for salaried employees and, for hourly employees, accrual of three to five weeks' vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits.Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact **************, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email *********************.The base salary range for this role is:$251,497.47-$339,859.45/Annual #J-18808-Ljbffr

Your mission The Commercial Quality Assurance Director will be based in Massachusetts and serve as the primary QA contact for commercial operations in the United States, maintaining close alignment with key partners in the United States and Europe. The position requires strategic leadership in developing and expanding a global Quality Management System, as well as extensive knowledge of GMP compliance and regulatory requirements. The Commercial Quality Assurance Director will also manage relationships with external partners, including CMOs, 3PLs, and distributors. The Commercial Quality Assurance Director will also oversee the quality of GMP development partners to ensure seamless integration across the product lifecycle. As we prepare for the launch of pritelivir in 2026, the Commercial Quality Assurance Director will play a critical role in supporting FDA inspection readiness and EMA submission activities while driving quality excellence across global operations. Lead the creation, review, and revision of SOPs to ensure commercial readiness and regulatory GMP compliance. Shape the evolution of the QMS to meet global commercial and regulatory GMP expectations. Implement recall procedures and perform mock recall to ensure recall procedures are adequate. Review, negotiate, maintain and manage quality agreements with CMOs, 3PLs, wholesalers and distributors. Serve as the primary QA contact for external commercial partners (e.g., CMOs, 3PLs, wholesalers, distributors). Develop and deliver training programs on commercial and GMP QA processes across all levels of the organization. Provide strategic oversight of GMP compliance across all outsourced manufacturing and packaging activities. Act as the QA liaison with internal stakeholders (e.g., Supply Chain, CMC, and Regulatory Affairs) and external service providers. Drive vendor qualification, audit strategy, and ongoing performance management. Lead / support internal and external audits, as required. Ensure inspection readiness for the FDA and support EMA submission activities within your area of responsibility. Prepare, review, and/or approve high-impact quality documentation, including batch records, deviations, CAPAs, change controls, product complaints and product quality reviews. Support product release processes and ensure timely QA support for supply chain operations. Drive continuous improvement initiatives within the commercial/GMP QA framework. Your profile Bachelor's, master's, or doctoral degree in a relevant scientific discipline (e.g., biology, chemistry, or pharmacy). Minimum 7 years of experience in biotech/pharma with exposure to commercial products. Deep understanding of FDA regulations (21 CFR Parts 210/211 and 600) and EU GMP (EudraLex, Volume 4) and global commercial quality standards. Proven experience in building and scaling QMS for commercial operations. Ideally, experience with computerized system validation in a GxP-regulated environment. Strong strategic thinking, communication, and stakeholder management skills. Detail-oriented with strong analytical and problem-solving abilities. Experience working in global regulatory environments and managing international QA operations is a plus. Ability to travel occasionally for audits, inspections, and team meetings. Close collaboration and alignment with the global QA team in Germany. Fluency in English. Why us? Unique corporate culture: Scientific excellence, a collaborative working environment and the passion to improve the lives of patients defines our work. With us, you can work together with innovation awarded experts with the proven ability to translate science into commercial success. You can expect diversity, inspiration, as well as trustful collaboration. Development: We encourage people to grow and strongly support individual development and learning opportunities. Flexibility: Embracing flexible working accommodations, we enable our people to integrate business into their personal life. Benefits: Competitive comprehensive benefit plan. #J-18808-Ljbffr

Monte Rosa Therapeutics is seeking a Director Quality GCP to provide strategic oversight of phase-appropriate Quality GCP and GCLP activities, including GCP quality oversight of ongoing quality activities supporting active pre-clinical and clinical programs through participation on in-house and external cross-functional teams. This role requires an 75% on-site presence. You will work closely with industry leaders in Boston and Basel . Join a diverse, collaborative, and dynamic team that values innovation, teamwork, and a people-centric culture! Responsibilities Primary GCP Quality contact for identified vendors and investigator sites supporting clinical programs as well as other GCP quality events (e.g., potential serious breach assessments, CAPAs) Author key GCP quality SOPs and key reviewer for other quality (GxP) procedures. Develop a risk-based GCP compliance program. Support teams in the initiation, review, and closure of quality events and associated CAPA, Change Action, and Effectiveness plans. Develop and provide GCP and other GxP training (as applicable). Ensure appropriate qualification of vendors and ensure compliant vendor management and regular assessment/audits. May conduct GCP audits (vendors and sites). Ensure audit observations are communicated, tracked and remediated. Provide QA GCP review and feedback on regulatory submissions. Lead and participate in inspection readiness activities for regulatory inspections - both internally and at clinical sites. Interface with internal departments and external vendors on a variety of technical/quality subjects. Qualifications BS Degree in Chemistry, Pharmacy, Biology or a related life science, or a combination of a BS Degree with relevant Quality and Technical experience. Minimum of 16 years of experience within the pharmaceutical or biopharmaceutical industry, with development experience and exposure to commercial operations. Knowledge and experience of clinical and commercial systems supporting GCP compliance with US and global regulations (FDA, EMA, ICH, MHRA, etc.). GLP experience a plus. Able to provide solution-minded approach and flexibility to emerging challenges. Able to appropriately balance priorities plus multi-task against competing priorities. Proven experience with the desire, and ability to work in a fast-paced, matrixed, start-up environment. Hands-on leader, able to provide solution-minded approach and flexibility to emerging challenges Understanding of drug development and program management preferred. #J-18808-Ljbffr

Introduction to role Are you ready to lead and innovate? As the Director of Patient Services Quality and Compliance, you'll play a pivotal role in ensuring the excellence of our Patient Support Programs for those on Alexion therapies. This is a new and critical position within our team, where you'll set strategic directions, collaborate with stakeholders, and implement ground breaking practices to meet regulatory and business requirements. Your leadership will drive the Patient Services Support Programs and Data Governance committee, leveraging the latest tools and technologies for efficiency. Are you prepared to make a difference? Accountabilities Responsible for ensuring that the PS quality processes and procedures meet regulatory requirements Lead Quality initiatives to ensure data integrity; periodic monitoring and oversight Assess and advise on the patient data governance activities & initiatives from a broader enterprise perspective Guide and advise on the key Patient data governance related decisions Recommend changes to policies, standards, and processes within patient data management Manage budgeting & resourcing for patient data initiatives and reviewing escalation requests Develop and evolve the PS quality assurance program, ensuring program execution matches key Work Instructions Periodic monitoring, review and manage changes to the Work Instructions to adjust to the changing business needs Ensure PS teams remain in compliance with key pharmacovigilance requirements through ensuring all employees and contractors have received required training, that all employees/contractors are aligned with adverse event (AE) and product complaint reporting, and that all remediation efforts are carried out per Work Instructions Implement critical tools and systems by automating repeatable tasks to improve efficiencies Work with Operations teams and other internal and external stakeholders to identify risks and areas for process improvement Oversee the execution and monitoring of internal and external audits Essential Skills/Experience Bachelor's degree in the Life Sciences or other relevant field 8-10+ years of Patient Services experience primarily leading the Quality and Compliance, patient safety functions Minimum 5 years of people management experience Proven track record working successfully in a fast-paced cross-functional environment with many stakeholders that have competing interests Comfort working through uncertainty while managing multiple, competing, and frequently shifting priorities Working knowledge of legal, regulatory, and compliance rules within the biotech/pharmaceutical industry Ability to work with external vendors during the SOW, PO, and project budget accrual processes Strong fluency in English (written and spoken language) Strong knowledge of MS Office and ability to create and edit documents using Microsoft PowerPoint, Excel, and Word Ability to present to internal and external stakeholders of 2 to 100+ people Ability to travel 30%+ of time, including weekend travel Desirable Skills/Experience Experience working in patient services or HUBs in the rare disease industry supporting a patient services organization Strong passion for digital advancement and an innovative mindset Working knowledge of salesforce.com, AI technologies and other best-in-class technology solutions Annual base salary for this position ranges from $180,875.20 to $238,000.00. AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances. In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks' paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program. Why Join Us? At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives. Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We align with all applicable laws and regulations on non-discrimination in employment and recruitment, as well as work authorization and employment eligibility verification requirements. We are using AI as part of the recruitment process. This advertisement relates to a current vacancy. Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E‑Verify. #LI‑Hybrid #J-18808-Ljbffr

A biopharmaceutical innovator is seeking a PV Quality and Compliance Associate Director. This critical role focuses on ensuring regulatory compliance in pharmacovigilance activities. The successful candidate will lead the development of the Quality Management System and manage audits. Requires a strong background in PV regulations, leadership skills, and experience in compliance initiatives. The position offers a competitive salary range of $150,000-$200,000 based on experience and location in Greater Boston. #J-18808-Ljbffr

A state health department is seeking a Chief Quality Officer to lead hospital quality initiatives and ensure regulatory compliance. Candidates must have a valid RN license in Massachusetts and extensive experience in quality/risk management, including managerial roles. The position involves collaboration with clinical teams to implement effective quality improvement strategies and ensure patient safety across the hospital system. The role offers a salary range of $100,839.08 - $155,529.95 per year with full-time scheduling. #J-18808-Ljbffr

Govern owned QMS applications, including harmonization of processes across sites. Responsible for requirements authoring and ongoing maintenance by leading and facilitating meetings/workshops with Site Process Owners and Key Users (Business SMEs). Approve validation deliverables including initial implementation and operational changes. Change ownership, including initiating and managing change through completion. Maintain system in a validated state, including periodic user access review, ongoing change management, business administration, and deviations/CAPAs associated with QMS. Lead and manage user forums for ongoing requirements gathering, prioritization, and triaging of issues. Lead and manage ongoing meetings with the vendor/IT as necessary. Report status and issues to governance committees/senior leadership. Communicate milestones and planned changes to user community promoting use of QMS. Responsible for representing owned QMS applications during inspections and explaining compliance. Train management and onboard new users to the system. Ensure Periodic Reviews (PR) are conducted per required frequency and approve PR Reports. Support Quality System Vendor Audits as a Business SME. Support KPI reporting and lead commitment meetings. Manage regular system updates/releases and assess and recommend new features. Ensure key user-related documentation is maintained and kept up-to-date as new functionalities are enabled, created and/ or modified. Investigate, escalated, and resolve issues identified on system. Execute/facilitate regression testing associated with system upgrades/project implementation. Participate in user forums/industry groups to garner best practice and represent Alkermes. Identify opportunities for continuous improvement and prioritize and manage associated change to completion. Qualifications Bachelor's degree in Computer Science, Engineering, or related field and five years of experience implementing and maintaining regulated systems. Experience must include five years each of the following: project management; development of user procedures; and SaaS (Software as a Service Solution)/cloud solutions. Experience must include one year each of the following:TrackWise Digital, ComplianceWire, and Veeva; system testing in a regulated industry; quality systems processes in commercial/clinical pharma/healthcare facility; US FDA, ICH guidelines, and European regulatory requirements; GAMP; and development of CBT (computer-based training) modules. Experience may be gained concurrently. The annual base salary for this position ranges from $141,000 to $146,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website:************************************* . #J-18808-Ljbffr

The Assurance Manager, Resource Management & Operations supports practice management needs in one or more of the following areas: scheduling, professional development and training, reporting and analysis. For example, the Manager may direct, organize, and plan the scheduling of practice managers and associates for work assignments based on project requirements and skill profiles. In this role, the Manager may coordinate associates' qualifications and proficiencies with the clients' job requirements to enhance final work product, and evaluate and assess productivity on an individual and group level. In addition, the Manager may serve as a liaison with Human Resources to determine future staffing needs and track training needs for personnel in the department. Job Duties: Directs the scheduling of associates for work assignments based on skill level, industry knowledge and experience, availability and preference Utilizes the planning schedule to determine the time frame and qualification requirements for client engagements Maintains a 12-month rolling schedule and provides quarterly assessment and adjustments as necessary Identifies key measurement factors to effectively allow for planning of future staffing needs Prepares project status reports and keeps management informed of project status and related issues Directs and maintains BDO RISE and third-party vendors assignments, as applicable Maintains an up-to-date skill profile of associates in order to successfully build teams to complete engagements in a timely manner Supports BDO's career advisor program by matching new and experienced hires with professionals to enhance personal growth May coordinate with practice managers and associates to assist in effective career advisors Monitors unassigned resources and acts as a primary point of contact for unassigned staff; proactively identifying assignments to ensure productivity Monitors national training requirements for practice managers and associates and facilitates compliance May identify training needs for practice managers and associates and facilitate the meeting of those needs, including the conducting of training Liaise with National CPE and Local CPE Principal to provide relevant training to the practice managers and associates and ensure compliance with firm CPE requirements Monitors and evaluates the department's productivity through analysis and reports Prepares comparisons to budgets, goals and prior year results at the individual and group level Identifies irregularities in monthly, quarterly and annual results and investigates accordingly Assist in the forecast process to help quantify resources needs Other duties as required Supervisory Responsibilities: Manages and oversees billing functions, including implementing best practices, supervising workflow and monitoring the billing related activities of customer accounts Qualifications, Knowledge, Skills and Abilities: Education: Bachelor's degree in Accounting, or Finance, required Experience: Three or more years of relevant experience, required Experience in a professional services firm, specifically public accounting, preferred Software: Proficient in the use of Windows and Microsoft Office Suite, specifically Word, Excel, and PowerPoint, Power BI, required Other Knowledge, Skills & Abilities: Excellent analytical skills Excellent communication skills and ability to foster and maintain relationships with professionals at all levels within the organization Ability to act as a strategic partner to regional and local business line and practice leadership and management teams Strong project and time management skills Excellent written communication skills Ability to maintain a high level of confidentiality and professionalism in all matters Ability to deliver presentations and facilitate meetings Ability to work well with a team as well as independently #J-18808-Ljbffr

Schedule: Mon-Fri (4 days in office required, 1 day optional remote) Compensation: Competitive Salary + Benefits We are a fast-growing AI language technology company seeking a US/LATAM Spanish Linguistic Quality Lead (LQL) to join our AI-focused language team on a mission to build the next generation of operational models. This is a unique opportunity for someone passionate about languages and technology, with the drive to shape the future of AI-powered communication in medical and life sciences translation. What You'll Do Lead linguistic quality assurance for US/LATAM Spanish, with a strong focus on medical device manuals, pharmaceutical content, and other regulated life sciences materials. Train large language models (LLMs) with Spanish linguistic data to enhance AI-driven translation, QA, and automation workflows. Translate, review, and edit Spanish content in active projects, ensuring accuracy, clarity, and regulatory compliance. Recruit, onboard, and manage Spanish linguistic resources (translators, editors, interpreters, interviewers) within our global network. Support project execution, ensuring linguistic excellence and cultural relevance across deliverables. Collaborate with other LQLs to drive workflow improvements and innovation, helping design future operational models. Partner with cross-functional teams at the intersection of language, life sciences, and AI. What We're Looking For Native proficiency in US/LATAM Spanish, with strong command of English. Ideal for your graduates with Spanish linguistic background. Familiarity with CAT tools (e.g., Phrase, Trados, MemoQ, XTM) is a plus but not required. Forward-thinking, creative, and energetic, with a willingness to take on challenges and think outside the box. Diligent, dependable, and committed to quality and continuous improvement. Strong organizational, communication, and problem-solving skills. Ability to work collaboratively with other LQLs, engineers, and project teams in a fast-paced, innovative environment. Work authorization in the U.S. is required. What We Offer Full-time role: Monday-Friday, with 4 days in-office and 1 day optional remote. Competitive salary + paid holidays, sick/personal days, and professional development opportunities. A modern office in Boston's Financial District. The chance to contribute to an AI-driven language team pioneering future business and operational models. A dynamic, entrepreneurial environment where your ideas and contributions have direct impact. This is an exciting role for someone passionate about Spanish language and culture, eager to explore AI-powered translation and linguistic innovation, and motivated to grow with a company shaping the future of language operations in medical and life sciences. How to Apply: Please send your CV to **********************

Title: Quality Systems & Investigations Specialist Employment Type: Contract Status: Accepting Candidates About the role This position plays a key role in supporting daily manufacturing activities by resolving operational issues and driving high-quality investigations. The role ensures process reliability through strong technical oversight and collaboration with critical operations teams. Key Responsibilities • Lead real-time floor support, triaging deviations and initiating root cause investigations. • Produce thorough, compliant quality documentation for deviations, CAPAs, and impact assessments. • Partner with manufacturing, QC, facilities, and materials teams to define corrective and preventive actions. • Apply structured scientific thinking to evaluate data and support operational decisions. • Contribute to process improvement by identifying trends and proposing optimized workflows. Qualifications • 6+ years experience in pharma/biotech manufacturing environments. • Proven background in investigations, RCA, QC analytics, and GxP documentation. • Skilled in cross-functional coordination and rapid issue assessment. • Strong analytical mindset with the ability to interpret complex data sets. • Experience supporting manufacturing operations in fast-paced, regulated environments. Compensation (MA Pay Transparency): • Estimated hourly range: $50-$58/hr (W-2). • Final rate within this range will be based on skills, experience, and interview results.

Pay Rate: $40-$50/hr Work Model: Hybrid (Onsite Tuesday, Wednesday, Thursday) The Quality Systems Specialist, under the direction of the QS&C management team, supports global Quality Systems to ensure compliance, operational effectiveness, and fitness for intended use in alignment with applicable global SOPs. Key Areas of Accountability Quality System Governance & Support Assist in governance of Quality System applications, including harmonizing processes across sites Participate in meetings/workshops with Site Process Owners and business SMEs to gather requirements for system improvements and ongoing maintenance Join user forums to collect ongoing requirements, prioritize needs, and triage issues Follow up on requests, issues, and project activities; provide status updates to managers and working teams Change Control & Compliance Initiate and manage change controls through completion, including all required documentation Ensure systems remain in a validated state by supporting periodic user access reviews, change management, business administration, and deviations/CAPAs Support investigation, escalation, and resolution of system-related issues Validation & Documentation Support validation activities, including: Requirements gathering Validation planning Design qualification Authoring and executing test plans and test scripts Discrepancy management Preparing system descriptions and validation summary reports Maintain user-related documentation and ensure updates as new functionalities are introduced Cross-Functional & User Support Assist manager with communication between vendor/IT teams Provide customer support through system administration, training management, and onboarding of new users Generate metrics to support Quality Systems performance Support regular system updates/releases and provide assessments and recommendations on new features Academic & Technical Qualifications Bachelor's degree or higher in a relevant computer, technical, quality, or scientific discipline (multi‑disciplinary background preferred) 3-6 years of experience in a high‑volume commercial or clinical pharma/healthcare environment Proficiency in MS Word, Excel, and Quality System processes Experience with Veeva Vault Quality Docs, TrackWise, and ComplianceWire is a plus Strong understanding of US FDA and European regulatory requirements, GAMP, and phase‑appropriate compliance expectations Knowledge of Regulatory Compliance and ICH Guidelines General Comments Position Title: Quality Systems Specialist Pay Rate Range: $40-$50/hr

Discover Veranova: At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference. Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients. Role Overview: This role provides Quality Assurance (QA) support for bioconjugation processes and GMP manufacturing of APIs and intermediates, ensuring compliance with global quality standards and regulatory requirements. This role will oversee key quality activities including deviation management, change control, batch record review, and product disposition, while driving continuous improvement and compliance initiatives. As a leader within the Quality Operations team, the QA Supervisor will guide and develop team members, collaborate across functions, and shape the strategic direction of quality within the organization. Core Responsibilities: Lead Quality Assurance oversight for bioconjugation manufacturing, ensuring GMP production and release of conjugated APIs, linkers, and payloads meet client expectations, timelines, and quality standards. Provide hands-on QA support on the production floor during conjugation, purification, and filling operations to ensure compliance with cGMPs, SOPs, and company policies. Oversee the review and approval of deviations, change controls, CAPAs, batch records, specifications, and other controlled quality documentation. Coach, mentor, and develop QA staff, providing guidance on quality systems, compliance practices, and real-time problem solving. Drive operational excellence by aligning local QA initiatives with global objectives and promoting a culture of quality and compliance across the organization. Support audits, investigations, and regulatory inspections, ensuring timely follow-up and continuous improvement in processes and systems. Evaluate complex quality or cross-functional issues using a risk-based approach and ensure CDMO partners meet Quality Agreement and regulatory expectations. Prioritize and allocate QA resources effectively to meet business demands and production schedules. Serve as a key client interface for Quality topics, fostering strong relationships and clear communication on regulatory and quality matters. Contribute to organizational quality strategy by participating in forums, continuous improvement initiatives, and talent development efforts. Qualifications: Required Minimum 9 years of quality assurance (QA) experience in a GMP manufacturing setting, preferably within a CDMO or API/intermediate facility, with an undergraduate degree in engineering, science or related field; or a minimum 7 years of QA experience with a graduate degree in engineering, science or related field Proven leadership experience in pharmaceutical, API/intermediate, medical device, biologics or related FDA industry Demonstrated proficiency and knowledge of cGMP, ICH, and other US and worldwide regulatory requirements Working knowledge of US & EU GMP, ICH Q7 and Part 11 compliance Proven ability to drive complex projects from initiation to completion, with strong analytical, problem-solving, and attention-to-detail skills. Demonstrated experience working effectively both independently and in team settings, including prior people management or team leadership. Excellent communication, interpersonal, networking, presentation, and influencing skills to build and lead cross-functional relationships. Embodies and promotes Veranova's culture, fostering an inclusive, positive work environment and delivering exceptional business results. Strong collaborative mindset with the ability to motivate, develop, and inspire others while effectively managing priorities and responsibilities. Preferred Direct experience with bioconjugation processes (e.g., linker/payload attachment, conjugated intermediates) is strongly preferred. Familiarity with HPAPI handling and containment requirements a plus Certified Lead Auditor certificate, or certification(s) in Lean manufacturing methods/tools such as structured problem solving, Lean Six Sigma, etc. Salary Range: $125,000 - $140,000 annual base salary Our Commitment: Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies. Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs. Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs. Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you don't meet every qualification, we encourage you to apply. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team. Additional Information: Applicants for this role must be authorized to work in the United States without further employer sponsorship. Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting. All your information will be kept confidential according to EEO guidelines. Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law. All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice .

Aerospace & Defense Quality Engineer - 6-Month Contract The Quality Engineer will be responsible for the development, implementation, maintenance, and continuous improvement of quality assurance processes in a regulated aerospace and defense environment. This role requires a strong data-driven mindset and hands-on quality engineering expertise to ensure compliance with AS9100/ISO standards, customer requirements, and regulatory obligations. Responsibilities Identify, analyze, and resolve quality issues using structured problem-solving methodologies Perform loss reporting and drive continuous improvement initiatives Design and implement process control, process improvement, testing, and inspection methods Develop, execute, and analyze quality metrics and reporting to support data-driven decision-making Perform and review First Article Inspections (FAI) in accordance with AS9102 requirements Interpret and apply GD&T per ASME Y14.5 to support inspection planning, nonconformance resolution, and root cause analysis Ensure compliance with AS9100 and applicable ISO standards across manufacturing and inspection processes Support and participate in internal, customer, and third-party quality audits Collaborate cross-functionally with engineering, manufacturing, and supply chain teams to ensure quality requirements are met throughout the product lifecycle Qualifications Bachelor's degree in Mechanical, Electrical, Manufacturing Engineering, or a related field (or equivalent experience) 4+ years of quality engineering experience in aerospace, defense, or another regulated manufacturing environment Strong working knowledge of AS9100, ISO 9001, and aerospace quality system requirements Experience performing and reviewing First Article Inspections (AS9102) Proficiency in interpreting engineering drawings and GD&T per ASME Y14.5 Strong knowledge of industry quality tools (e.g., SPC, FMEA, root cause analysis, CAPA) Demonstrated analytical, data-driven approach to problem solving Strong communication, documentation, and audit-support skills To learn more or apply, please contact me at ****************************. BioTalent Ltd is acting as an employment agency in relation to this opportunity.

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess' patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world. The Role: The Quality Engineer I / II will support Quality Assurance activities for Vaxess' combination product programs, with a strong focus on medical device design controls, risk management, and cGMP compliance. This role provides hands-on quality support across design and development, supplier oversight, process validation readiness, and batch record/data review, aligned with ISO 13485, 21 CFR 820, and applicable combination product regulations (21 CFR 4). Reporting to the Quality Assurance Manager, this role works cross-functionally with Manufacturing, Process Development, Quality Control, and Material Management to support compliant execution and ensure product quality and safety during early clinical development. Responsibilities: Support quality oversight of Vaxess combination product(s) to ensure compliance with safety, efficacy, and regulatory requirements. Administer and support the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR 820, 21 CFR Part 4 (Combination Products), and applicable FDA and international regulations. Provide quality support for Design Control activities, including Design History File (DHF) maintenance, design reviews, Design Verification and Validation (DVV), and design changes. Support risk management activities, including development and maintenance of risk analyses (e.g., FMEA, hazard analyses) and linkage to design and process controls. Support process validation and qualification activities, including test method validation (TMV), process validation (PV), and equipment qualification, as applicable to Phase I and GMP-ready manufacturing. Participate in Material Review Board (MRB) activities, including nonconformance assessment, disposition, and documentation. Perform quality review and approval of batch records, executed manufacturing records, analytical data collection forms, test records, and technical or experimental reports. Collaborate in supplier quality management activities, including supplier qualification, auditing, monitoring, change evaluation, and periodic requalification. Author, review, and revise quality documentation, including SOPs, work instructions, test methods, protocols, reports, forms, and specifications. Support preparation, review, and organization of quality data and documentation for regulatory submissions and inspections. Contribute to continuous improvement initiatives within the QMS, including CAPA, deviation investigations, and quality metrics. Qualifications: Quality Engineer I: Minimum of 3 years of experience in Quality Assurance or Quality Engineering within a cGMP-regulated medical device or combination product environment. Quality Engineer II: Typically 4-5 years of progressive quality experience in medical devices, pharmaceuticals, biologics, or combination products. Working knowledge of ISO 13485 and FDA medical device Quality System Regulations (21 CFR 820); familiarity with combination product requirements strongly preferred. Experience supporting early-phase (preclinical to Phase I) product development is highly desirable. Experience with design controls, risk management (FMEA), and validation activities preferred. Experience reviewing GMP documentation such as batch records, test methods, protocols, and reports. Strong written and verbal communication skills, with the ability to clearly document technical and quality concepts. Proficiency with Microsoft Office applications (Word, Excel, PowerPoint). At Vaxess, we're bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to ****************** .

A leading global biotechnology firm in Boston seeks a Principal Engineer to lead the automation of pre-clinical data pipelines and regulatory reporting solutions. This role focuses on driving modernization and standardization initiatives, leveraging AI technologies, and enhancing data consumption practices. Candidates should possess strong programming skills and a degree in a relevant field, with a minimum of five years in technical leadership within the biotechnology industry. The position offers a hybrid work model and a comprehensive benefits package. #J-18808-Ljbffr

A biotechnology company in Massachusetts is seeking a Commercial Quality Assurance Director to lead quality assurance for commercial operations. This role involves developing a global Quality Management System, managing relationships with partners, and ensuring FDA inspection readiness while promoting quality excellence across operations. Ideal candidates will have extensive experience in biotech/pharma, deep understanding of regulatory requirements, and strong strategic and analytical skills. A flexible work environment and competitive benefits are offered. #J-18808-Ljbffr

A digital health technology company is seeking a Director of Regulatory Affairs and Quality Assurance to lead regulatory compliance and quality frameworks for their medical-grade digital health products. This role involves overseeing FDA submissions, ensuring quality management systems meet global standards, and mentoring a high-performing regulatory team. The ideal candidate will have a strong background in regulatory affairs, experience with medical devices, and the ability to thrive in a fast-paced environment. Competitive salary offered in Boston, MA. #J-18808-Ljbffr

A biopharmaceutical company in Boston seeks a Director Quality GCP to oversee quality compliance for clinical programs. The role requires extensive experience in pharmaceutical regulations and vendor management, with a focus on developing quality SOPs and leading audits. Ideal candidates will have over 16 years of experience in the industry, a relevant degree, and the ability to thrive in a dynamic start-up environment. #J-18808-Ljbffr

A leading medical products company is seeking a Vice President of Global Quality Assurance and Regulatory Affairs in Boston. The successful candidate will lead QA/RA efforts, ensuring compliance with FDA and international standards while collaborating with teams across the organization. Candidates should have over 10 years of relevant experience in the medical field, strong leadership skills, and a proven track record in regulatory affairs. This full-time position offers competitive compensation and a suite of benefits. #J-18808-Ljbffr