QA Manager- Finished Goods Commercial
$118.4k - $177.6kVertex Pharmaceuticals
- # QA Manager- Finished Goods CommercialApplylocations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-29054**Job Description****General Summary:**The Quality Manager provides oversight of department activities, ensuring alignment with corporate goals and regulatory requirements. This includes managing multiple complex projects, troubleshooting issues, and fostering collaboration with business partners and stakeholders to ensure the continuation of supply in all markets. The Quality Manager will also be responsible for overseeing and managing the end-to-end product disposition process for Finished Goods. This role ensures timely and compliant product release by overseeing data readiness and collaborating with Contract Manufacturing Organizations (CMOs) and internal teams to implement continuous improvement measures. The position reports to the Associate Director and plays a critical role in driving quality initiatives and maintaining the integrity of deliverables**KEY RESPONSIBILITIES**Key Responsibilities of the position may include, but are not limited to the following:**Product Disposition Management*** Oversee product disposition for Finished Goods, ensuring compliance with regulatory and quality standards.* Collaborate with Contract Manufacturing Organizations (CMOs) to resolve disposition-related issues and align on timelines and quality expectations.* Review of Executed Batch Records (EBRs) for commercial packaging operations and resolution of comments with CMOs* Review of impacting change controls against full lot genealogy to determine if material is compliant in relevant region(s), make disposition decision, and perform batch release* Evaluations of Investigations/ OOS/ Change Controls to support Disposition Decision* Assist with EAC and Material Review Board activities, when necessary* Manage data readiness for product disposition, including batch records, Certificates of Analysis (CoA), and supporting documentation.* Proactively manage and improve disposition processes to meet turnaround times.**Stakeholder Collaboration*** Develop and manage relationships with strategic external partners in support of Vertex’s expanding commercial portfolio and manager ongoing relationships. As CMO lead, be responsible for management of QA relationships with one or more CMOs.* Act as the primary QA contact for disposition-related queries and escalations.* Collaborate with internal teams (e.g. MS&T, External Manufacturing, Supply Chain, Regulatory) to ensure alignment and timely resolution of quality events.**Compliance and Continuous Improvement*** Provide quality guidance for root-cause analysis, product impact assessments, and CAPA actions.* Support GMP/GDP management reviews, risk assessments, and mitigation strategies.* Identify and implement process improvements to enhance internal QA processes as well as Vendor performance.* Lead and / or represent FG QA in cross-functional initiatives / continuous improvement projects.**Communication*** Prepare and present (as needed) operational and quality reports, including disposition performance metrics, trends, risks, and mitigation plans.* Provide regular updates on disposition activities, CMO management and improvement initiatives.**Audit and Inspection Support*** Serve as SME responder and provide support for audit/inspection preparation, execution, and post-inspection activities.**MINIMUM QUALIFICATIONS:*** Bachelor’s degree in Life Sciences, Pharmacy, or a related health field.* 4+ years of experience in pharmaceutical manufacturing (Packaging and Labelling Operations preferred), quality assurance, or Finished Goods product disposition.* Strong knowledge of global GMP requirements and oral drug product manufacturing practices.* Proficiency in data analysis and visualization tools.* Excellent communication, collaboration, and project management skills.**PREFERRED QUALIFICATIONS**:* Strong leadership skills with the ability to thrive in a high throughput environment* Attention to detail* Critical Thinking / Problem Solving + Ability to evaluate quality matters and make decisions utilizing risk-based approach* Project Management / Continuous Improvement o Ability to lead and manage projects/teams within corporate objectives and project timelines o Proficient in utilizing project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks o Demonstrated ability to work independently to provide QA support for large, multifaceted projects* Collaboration / Teamwork / Conflict Management o Ability to independently lead cross-functional teams and represent the Quality unit o Ability to understand and translate business needs o Recognized as a mentor with a strong ability to transfer technical knowledge and teach skills to junior staff o Represents Vertex Commercial Quality Assurance on cross functional working teams and is recognized for strong communication and influencing skills* Flexibility/Adaptability* Knowledge in the following areas: o Expert knowledge of global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices o GMP/GDP regulations and application to Manufacturing and Testing risk management principles o Root Cause Analysis tools/methodology* Broad GxP Knowledge and understanding across lifecycle of the product* Sense of urgency - ability to act quickly/escalation process/transparency**Pay Range:**$118,400 - $177,600**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.
- J-18808-Ljbffr Vertex Pharmaceuticals
Vacancy posted 17 hours ago
Similar jobs that could be interesting for youBased on the QA Manager- Finished Goods Commercial in Boston, MA vacancy
- Vertex Pharmaceuticals seeks a QA Manager to oversee quality assurance for Finished Goods in Boston. This role involves managing product disposition processes and collaborating with CMOs to meet regulatory standards. The ideal candidate has a Bachelor’s in Life Sciences...Commercial
$118.4k - $177.6k
General Summary The Quality Manager provides oversight of department... ...‑end product disposition for finished goods, ensuring timely and... ...executed batch records (EBRs) for commercial packaging operations and resolve... ...partners and maintain QA relationships with one or more...CommercialContract work$118.4k - $177.6k
Vertex Pharmaceuticals Inc (US) is seeking a Quality Manager to oversee the management of product disposition for finished goods, ensuring compliance with regulatory standards. The ideal candidate will have a Bachelor's degree in Life Sciences and at least 4 years of experience...Suggested- Vertex Pharmaceuticals Incorporated in Boston is seeking a Quality Manager responsible for overseeing product disposition and ensuring compliance with corporate goals and regulatory requirements. You will manage key relationships with Contract Manufacturing Organizations...SuggestedContract work
- ...- Aseptic Processing & Fill/Finish page is loaded## Principal Engineer... ...goals from Strategy to Commercialization. As the only firm born from... ...(like USP , Annex 1) and managing inspections/deviations.* **Aseptic... ...in accordance with current Good Manufacturing Practices.*...CommercialWork at office
- ...Summary The Quality Assurance Manager is responsible for development and maintenance of all QA programs, meeting USDA, FDA and... ...quality and safety of supplied goods. Must have strong knowledge in... ...accurate allergen labeling on finished food products and prevention of...Work at officeLocal areaFlexible hours
- Lead Pastor Good News Bible Church, Wilton, NH Are you a passionate man of God with a deep love for Jesus and His Church? Are you... ...The community sits within easy reach of major employment and commercial centers—just 20 minutes from Nashua and within commuting distance...Commercial
$177.5k - $222k
...reliability, compliance risks, and vendor footprint. Acquisition & Commercial Readiness: Drive the audit-readiness strategy to ensure assets... ...-stage to commercial. You have a proven track record of managing program-level risk management frameworks and successfully...CommercialWork at officeLocal areaRelocation3 days per weekFormation Bio (Formerly TrailSpark)
Boston, MA17 hours ago$124.43k - $155.47k
...individual with some sales background to manage our Boston territory. This Service Center... ...utilities, data centers, renewable energy, commercial and industrial industries.... ...communication, supervisory, organizational, and good management skills. Communicate effectively...CommercialWork experience placementLocal areaNight shift$160k - $240k
...Quality subject matter expert for Good Manufacturing Practices (GMP... ..., Drug Products, and Finished Goods. Collaborate with manufacturing... ...control and shelf life management. Ensure that product... ...-stage manufacturing and commercialization readiness activities. Skills...CommercialContract workKymera Therapeutics
Watertown, MA10 hours ago$130k - $165k
...Plymouth Rock Assurance is seeking an experienced and accomplished QA Manager to join our dynamic team. The successful candidate will play a... ...companies write and manage over $2.2 billion in personal and commercial auto and homeowner’s insurance throughout the Northeast and...CommercialShift workPlymouth Rock Assurance
Boston, MA3 days ago$285k - $350k
...of drug development, product launch and commercialization. This individual will lead the... ...activities, and commercial product lifecycle management. The Head of Quality will work cross-functionally... ...disciplines before transferring into a QA role: Chemical Development/...CommercialFixed term contractTreeline Biosciences
Watertown, MA4 days ago- ...directing and evaluating a quality assurance function and a quality management system which supports clinical development and regulatory... ..., ideally for products which were ultimately approved for commercial distribution, and regulatory inspections. Excellent judgment...CommercialTemporary workFor contractorsFor subcontractorFlexible hours
KMR Search Group
Boston, MA17 hours ago - ...Construction Estimator (Drywall & Interior Finishes) Location: Boston, MA Job... ...a key role in delivering high-quality commercial interior projects. If you enjoy turning... ...competitive, winning bids Partner with project managers, vendors, and subcontractors throughout...CommercialFull timeFor subcontractorWork at officeShift work
System One Holdings, LLC
Boston, MA4 days ago - ...technology company at the forefront of national security and commercial innovation, with a mission to push the boundaries of what autonomous... ...next-gen mission capability. About the Role As a UAS Test Manager, you will lead a test team in the development and execution of...Commercial
$71.28k - $106.92k
...Business Development Manager The Business Development Manager is responsible for successfully... ...to develop and present proposal, lead commercial strategy and customer negotiations,... ...their raw materials, components and finished goods. For more than 40 years, the Chicago-...CommercialWork at officeWorldwideFlexible hoursAIT Worldwide Logistics
Chelsea, MA4 days ago- ...income, and work closely with the management team and clients of... ...building amenities, unit plans, finishes, and construction details offered... ...through closing Maintain good relations with new buyers/... ...residential and multifamily commercial real estate - property management...CommercialContract workWork at officeLocal area
$155k - $205k
...Assurance to lead the transformation of our QA organization into a modern, automation-... .../CD-integrated automation and test data management. Evaluate and implement tools and... ...manage over $2 billion in personal and commercial auto and homeowner's insurance throughout...CommercialShift workPlymouth Rock Assurance
Boston, MA1 day ago$71.28k - $106.92k
...Overview The Business Development Manager is responsible for successfully supporting... ...to develop and present proposal, lead commercial strategy and customer negotiations,... ...procure their raw materials, components and finished goods. For more than 40 years, the Chicago-...CommercialWork at officeLocal areaWorldwideFlexible hoursAIT Worldwide Home Delivery
Chelsea, MA17 hours ago$215k - $275k
...this by optimizing every lever of their commercial strategy - customer engagement, product,... ...‑growth clients across Retail, Consumer Goods, and Leisure, Travel, & Tourism. We provide... ..., go‑to‑market strategy, revenue growth management (e.g., consumer pricing, price‑pack...CommercialWork at officeWork from homeFlexible hours$240k - $275k
...this by optimizing every lever of their commercial strategy - customer engagement, product,... ...growth clients across Retail, Consumer Goods, and Leisure, Travel, & Tourism. We provide... ...role is on expertise in Revenue Growth Management (RGM advisory) coupled with broader end-...CommercialWork at officeWork from homeFlexible hours$15 - $16 per hour
At JD Finish Line, we’re not just selling products; we’re creating experiences. Our retail... ...through effective merchandise management, promotional strategies, and achieving sales... ...circumstances, weights may be higher. Must have good vision, including color differentiation....Hourly payPermanent employmentTemporary workPart timeLocal areaImmediate startFlexible hoursNight shiftDay shift$190k - $200k
...this by optimizing every lever of their commercial strategy - customer engagement, product,... ...and high growth clients across Consumer Goods, Retail, and Leisure, Travel, & Tourism.... ...behavioral science. We are hiring a Senior Manager level Individual to support our growing...CommercialWork at officeWork from homeFlexible hours$110k - $150k
...systems. Role Information Title: Quality Manager Reports to: VP, Quality & Regulatory Affairs... ...& validation, clinical use, and commercial launch. You will own and run core QMS processes... ...on design controls, risk management, and good documentation practices Key Responsibilities...CommercialTemporary workCasual workWork at officeFlexible hoursPortal Instruments
Boston, MA2 days ago$115k - $145k
...Role Overview & Key Functions: Provide management-level leadership, business process... ...QMS processes, Veeva system navigation, good documentation practices, data integrity,... ...cancer. We are building upon an established commercial foundation in multiple myeloma while advancing...CommercialFor contractorsUnavailable
Newton Center, MA3 days ago- ...development and ongoing engagement Manage and maintain project activity... ...Current driver’s license in good standing; typical schedule of... ...high‑end residential and commercial sectors Own the client... ...trimming, sanding, glazing, and finishing tools Ability to safely operate...CommercialFull timePart timeFor contractorsWork at officeLocal areaWork from homeWeekend work
$89.8k - $170.5k
...Manager, Consumer Products Assurance RSM is looking for a Manager to join our Consumer Products Assurance team. You will have the opportunity to work as a team member on diverse client engagements as part of our national and local Consumer Products practice. Our clients...Work experience placementInternshipLocal areaRSM
Boston, MA17 hours ago$125k - $145k
...to the Director of Quality Control, the Manager, Quality Control will be responsible for... ...and global cGxP to support clinical and commercial operations. In addition, this role will provide... ...reflects what Nuvalent reasonably and in good faith expects to offer for this position...CommercialContract workSummer workLocal area- ...demonstrable, deep expertise in one or more commercial-grade Trade Order Management Systems. Should understand key... ...articulate solutions Help clients make good decisions Coaching Skills... ...Encourage and support team members QA/Testing Ensure robust testing within...CommercialWork at office
IMP Consulting
Boston, MA12 days ago - ...Licensing Manager TIDO | Boston Childrens Hospital Position Summary: Works with Children... ...sponsored research projects. Develops commercialization strategies for Children's intellectual... ...to go/no go decisions in order to be a good steward of BCH resources. Provides...CommercialWork at office
Children's Hospital Boston
Boston, MA3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to QA Manager- Finished Goods Commercial. Be the first to apply!
Related searches
- qa manager remote Boston, MA
- quality assurance manager Boston, MA
- quality assurance supervisor Boston, MA
- qa director Boston, MA
- qa manager Boston, MA
- quality assurance manager remote Boston, MA
- qa supervisor Boston, MA
- senior qa manager Boston, MA
- quality assurance qa manager Boston, MA
- commercial account manager Boston, MA