Director Quality Qualified Person - Europe
Director Quality Qualified Person - Europe
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Job Description
About SpringWorks Therapeutics:
SpringWorks is a commercialstage biopharmaceutical company applying a precision medicine approach to developing and delivering lifechanging medicines for people with severe rare diseases and cancer.
SpringWorks has a diversified targeted oncology pipeline spanning solid tumors and hematological cancers including clinical trials in rare tumor types and highly prevalent genetically defined cancers. SpringWorks strategic approach and operational excellence in clinical development have enabled it to rapidly advance its lead product candidates into latestage trials and enter into multiple collaborations with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer.
Your Role:
The Director Quality/Qualified PersonEurope has responsibility to establish and oversee the of GMP strategies for SpringWorks commercial portfolio in the EU/EEA and UK. The individual will oversee activities with a focus on ensuring compliant application of relevant GMPs across affiliate locations in the region. Accordingly the individual will serve as the primary GMP subject matter expert supporting all Quality aspects from importation through distribution. The Director Quality/Qualified PersonEurope will be responsible for assuring inspection readiness of SpringWorks locations in the EU/EEA and UK as well as our external partners responsible for the importation certification and distribution medicinal products.
Location Classification Hybrid:
This role will be required to work onsite 2 days a week (Tuesday and Wednesday) or more depending on business needs. #LIHybrid
Essential Duties and Responsibilities:
- Establishes appropriate GMP quality management system based upon continuous monitoring of established and emerging regulations guidance and directives.
- Develops and provides clear communication of organizational GMP quality objectives that combine compliance goals with those of the overall organization.
- Promotes a culture of integrity and compliance while driving sustainable performance and results.
- Provides timely escalation of compliance issues that may impact SpringWorks products to Senior Leadership.
- Identifies risks to compliance and ensures the implementation of appropriate mitigation strategies that assure compliance and business continuity.
- Establishes and maintains a high performing accountable Quality team inclusive of Responsible Persons across SpringWorks EU/EEA and UK locations which embodies the values of SpringWorks.
- Promotes and maintains effective relationships with internal crossfunctional stakeholders as well as external partners to foster an environment of compliance and ensure products meet the highest standards for safety purity and potency.
- Develops and maintains effective product quality oversight and medicinal product release processes for EU/EEA and UK markets according to 14 AMG EU Guide Annex 16 and other relevant regulations for the release of medicinal products.
- Proactively provides GMP compliance leadership and decisionmaking for commercialized medicinal products.
- Assures continued product compliance through implementation and management of a riskbased vendor management program.
- Implements and monitors quality metrics across affiliate sites in the region.
- Proactively identifies opportunities for continuous improvement and tracks to timely completion.
- Ensures Product Quality Reviews are completed within expected timelines.
- Ensures the implementation of a robust inspection readiness program to enable inspection success internally and externally inclusive of management of the selfinspection program.
- Establishes compliance expectations with outsourced partners through implementation of Quality Technical Agreements.
- Serves as the primary Quality stakeholder in selection of outsourced partners and negotiation of service agreements.
- Perform other duties and responsibilities as assigned
Role Requirements:
- Education: Bachelors or advanced degree in pharmacy chemistry biology or human medicine.
- 9 years with a Bachelors degree; or 7 years with a Masters degree; or 4 years with a PhD in the pharmaceutical industry supporting the medicinal product in a GMP Quality role.
- 4 years serving in a leadership role.
- 4 years serving as a Qualified Person.
- Indepth knowledge of manufacturing and testing processes employed for small molecules. Experience with both drug substance and drug products preferred
- Expert in latestage medicinal product cGMP and quality management requirements including EU and ICH regulations guidance and directives.
- Broad knowledge and working understanding of regulatory requirements for EU/EEA and UK.
- Experience in designing and implementing phase appropriate quality management system.
- Experience participating in and hosting regulatory inspections from global Health Authorities.
- Fluency (reading/writing/speaking) German and English
- Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams performance.
- Strong interpersonal communication skills to collaborate with colleagues stakeholders and vendors effectively and clearly in a remote hybrid work environment.
- Ability to travel occasionally including overnight stay driven by business need occasionally 20 of time or more)
SpringWorks Leadership Principles:
- Change Steward Recognize that change is essential; set goals that align to the Companys strategy and create positive momentum for change; adapt business practices as necessary to adjust to ever changing requirements
- Excellence Driver Drive high performance and ownership through an open dialog; recognize performance empower teams and create accountability for results
- Growth Coach Set clear expectations provide frequent feedback coaching and encourage continuous learning; leverage individual strengths to help SpringWorkers unleash their potential and grow in their jobs and careers
- Community Builder Establish connections with others to build strong teams that trust each other and are great at collaborating to achieve goals; create a diverse inclusive and psychologically safe environment
Compensation and Benefits:
We offer bestinclass benefits for our team of SpringWorkers who work with urgency on behalf of patients suffering from devastating diseases. Interested in learning more review additional information hereBenefits.
DE&I:
We believe in fostering a culture of belonging. Explore how we are committed toDE&I
EEO Statement:
SpringWorks maintains an EEO Policy providing for equitable opportunities for employment and conditions of employment to all employees and applicants regardless of actual or perceived sex (including pregnancy childbirth breastfeeding 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 caste 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 victims of domestic violence stalking or sex offense political affiliation and any and all other characteristics or categories protected by applicable federal state or local laws. SpringWorks treats all employees and applicants fairly in the selection process (and in other personnel activities) by giving all employees and applicants the same opportunities for employment. SpringWorks Equal Employment Opportunity Policy is intended to ensure that there are no barriers that would prevent members of a protected group from a fair and equitable opportunity to be hired promoted or to otherwise take advantage of employment opportunities.
This Equal Employment Opportunity Policy applies toallaspects 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.
Privacy:
Upon submission of this form I understand that SpringWorks Therapeutics is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S.. Information about SpringWorks Therapeutics privacy practices can be found atPrivacy Policy Springworks springworkstx.
Required Experience:
Director
Employment Type
Full Time
