GMP Quality Assurance Senior Manager

Springworks • Remote

Company

Springworks

Location

Remote

Type

Full Time

Job Description

About SpringWorks Therapeutics

SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for patients living with severe rare diseases and cancer. SpringWorks has a differentiated targeted oncology pipeline spanning solid tumors and hematological cancers, including two late-stage clinical trials in rare tumor types as well as several programs addressing highly prevalent, genetically defined cancers. SpringWorks’ strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer. 

We give it our all every day because we believe in the power of targeted oncology to help people with cancer. If you recognize yourself in us, then we’d like to meet you. The answers are waiting – and we need your help finding them.  

About the Role:

This individual will report into the Director Global GMP Quality Assurance and play an essential role in maintaining and supporting a reliable and compliant supply of SpringWorks products to clinical sites and commercial distribution outlets. Primary responsibilities entail being Quality point of contact for one or more SpringWorks products. This involves working with internal (CMC/product development) and external stakeholders (CMOs) to meet SpringWorks’ timelines for finished drug product release for clinical trial or commercial market supply.  

Responsibilities Include:

  • Manage SpringWorks Quality Unit review and approval of CMO master documentation (e.g. specification documents, master batch records, label proofs, etc.) as well as executed batch records, QC release records, and stability test records for the manufacturing of drug substance and drug product. 
  • Work with Qualified Persons (QPs) to support QP certification for distribution of SpringWorks products to EU/UK clinical trial sites (Annex 16). 
  • Perform QA oversight of stability protocol data review and expiry dating of SpringWorks products 
  • Work with internal stakeholders and/or CMOs to perform deviation investigations in support of product quality (as applicable).  Escalating to SpringWorks Senior Management, when necessary. 
  • Work with internal stakeholders and/or CMOs to initiate and implement change controls 
  • Participate in GMP compliance audits and complete risk assessments for supplier qualification (as required). 
  • Develop and implement procedures to support the evolution of the Quality Management System, as required. 
  • Serve as the delegate of the Director, GMP QA to represent GMP QA as directed. 
  • Drive PAI readiness activates to ensure CMOs for DS and DP are inspection ready.
  • Perform surveillance of the GMP space for new regulations or emerging regulatory trends and develop method/process to keep organization informed.  
  • Perform other duties and responsibilities as assigned.

About You: Required Education, Skills, and Experience

  • Education: Bachelor’s degree in a scientific or technical discipline. 
  • 5+ years’ experience working in Quality Assurance in a pharmaceutical/regulated environment/industry 
  • Prior experience overseeing CMO quality for batch record review, deviation investigation resolution for drug substance and finished drug product. This could be a combination of working in Quality Operation/Manufacturing roles 
  • Working level knowledge of key quality systems such as change controls, deviations, CAPAs, product complaints, and supplier qualification 
  • Appreciation of quality risk management concepts 
  • Proficiency in ICH Q10 requirements 
  • Working knowledge of 21CFR US FDA regulations, ICH guidance, and Eudralex GMPs 
  • Experience with regulatory inspections is preferred. 
  • Regularly interacts with senior management or executive levels on matters concerning several functional areas. Requires the ability to influence the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship or the goals of the organization  
  • Supports SpringWorks Values and Strategy 
  • Prioritizes activities to meet the needs of the company 
  • Ability to influence and drive decisions with key stakeholders 
  • Ability to articulate requirements to key stakeholders verbally or in writing. 
  • Establishes routine cadence of communication with key stakeholders 
  • Engages SME’s to support positions and decisions 
  • Strong negotiation and influencing skills with internal and external stake holders 
  • Excellent verbal and written communication, strong organizational and interpersonal skills 
  • Proficient in the use of MS Word, MS Excel, MS PowerPoint 
  • Experience with Veeva Vault, preferred 
  • Experience with SAP, preferred
  • This position must be able to work East Coast hours.
  • If position sits remote ability to travel occasionally including overnight stay (<15%).

The expected salary range for this position is $125,500.00 - $165,000.00. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

We also offer a comprehensive benefits package for our team of SpringWorkers and their families, including competitive compensation, annual cash bonuses and equity grants, 401K matching, fully covered medical, dental, and vision plans, and a full week of holiday break at year end. It’s the right thing to do – and helps us be healthy, happy, and at our best for the people who need us.


At SpringWorks, we believe in fostering a culture of belonging. Our Employee Resource Group’s (ERG) mission is to boldly live the SpringWorks values, provide resources, and deeply engage SpringWorkers and the communities we serve to foster a culture of belonging. Ensuring diversity, equity, and inclusion are integral to our organization’s DNA. 

SpringWorks is an equal employment opportunity employer that is strongly committed to equal employment opportunities for all individuals. The Company does not discriminate in employment opportunities or practices on the basis of actual or perceived sex (including pregnancy, childbirth, breast feeding or related medical conditions), gender, gender identity or gender expression, sexual orientation, partnership status, marital status, familial status, pregnancy status, race, color, national origin, ancestry, religion, religious creed, age, alienage or citizenship status, veteran status, military status, physical or mental disability, past or present history of mental disorder, medical condition, AIDS/HIV status, sickle cell or hemoglobin C trait, genetic predisposition, genetic information, protected medical leaves, domestic violence victim status, sex offense or stalking victim status, political affiliation and any and all other characteristics or categories protected by applicable federal, state or local laws.

This Equal Employment Opportunity Policy applies to all aspects of employment, including, without limitation, recruitment, hiring, placement, job assignment, promotion, termination, transfer, leaves of absence, compensation, discipline, and access to benefits and training. Any violation of this Policy will result in disciplinary action up to and including termination of employment.

GDPR Statement:  When you apply to a job on this site, the personal data contained in your application will be collected by SpringWorks Therapeutics (“Controller”), which is located at 100 Washington Blvd, Stamford CT 6902 and can be contacted by emailing [email protected] . Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. Because the European Union Commission has determined that United States data privacy laws do not ensure an adequate level of protection for personal data collected from EU data subjects, the transfer will be subject to appropriate additional safeguards under the standard contractual clauses. You can obtain a copy of the standard contractual clauses by contacting us at [email protected].

Your personal data will be retained by Controller for as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with an EU supervisory authority.

Apply Now

Date Posted

05/25/2023

Views

19

Back to Job Listings ❤️Add To Job List Company Info View Company Reviews
Positive
Subjectivity Score: 0.9

Similar Jobs

Senior Data Scientist - Canva

Views in the last 30 days - 0

Canva seeks a Regional Data Lead for LATAM to build data strategies collaborate with global teams and drive growth The role offers equity flexible lea...

View Details

Senior Frontend Engineer - Arize AI

Views in the last 30 days - 0

Arize AI a leading observability platform with 135M funding and 150 enterprise customers seeks a Senior Frontend Engineer to build scalable intuitive ...

View Details

Senior Data Scientist - Dropbox

Views in the last 30 days - 0

This job description outlines a Senior Data Scientist role focused on driving impact through AI and core experience improvements The position requires...

View Details

Account Manager for Telco - Canonical

Views in the last 30 days - 0

Canonical promotes opensource innovation offering enterprise solutions and hiring top talent to drive growth and leadership in the tech industry The c...

View Details

Senior Software Engineer - Mozilla

Views in the last 30 days - 0

Mozillas mission is to build an open internet focusing on privacy and innovation They offer impactful roles like Senior Software Engineer at AMO with ...

View Details

Customer Experience Associate New Req - Koala Health

Views in the last 30 days - 0

Koala Health promotes a missiondriven role with competitive pay and benefits emphasizing joyful pet healthcare experiences and a supportive team envir...

View Details