Quality Systems Compliance Associate Director
Quality Systems Compliance Associate Director
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
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 Quality Systems and Compliance Associate Director is responsible for the establishment and continuous improvement of an effective compliant and fit for purpose quality management system. The major activities include but are not limited to the following: management and facilitation of the Approved Vendor List (AVL) scheduling of audits deviation investigations CAPAs supplier audit closures support of regulatory inspections SOP writing and revision Quality Council and change controls. In addition this individual will support the end to end of supplier quality that includes Supplier Periodic Reviews.
This individual will also serve as the Veeva QMS business owner that will lead change management strategies that will improve Veeva functionality and increase efficiency for the end user and will support the SpringWorks Inspection Management process and provide regulatory intelligence regarding new regulations regulatory authority guidance and enforcement.
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:
- Establish a riskbased supplier quality program that considers criticality regulatory requirements and business impact.
- Maintain Quality Management System (QMS) appropriate regulations and international and national regulations are aligned with regulatory agency expectations.
- Ensure timeliness of Quality System closures (e.g. deviations change controls and CAPAs).
- Establish implement and maintain master audit schedule as part of the overall quality strategy
- Interact with internal & External stakeholders including peers and Senior Management (Procurement Clinical Regulatory Affairs etc. to align supplier quality goals for the company.
- Generate Quality System metrics reports to report at Quality Council as per procedure.
- Act as the point person for Veeva QMS Business Owner to create operational efficiencies for end user experiences.
- Risk Management
- Perform surveillance of the GxP space for new regulations or emerging regulatory trends and develop method/process to keep organization informed
- Perform other duties and responsibilities as assigned
Role Requirements:
- Education: 7 years of related experience with a Bachelors degree in Life Sciences; or 5 years and a Masters degree; or a PhD with 3 years experience; or equivalent experience
- 7 years of Qualityrelated experience in a pharmaceutical or biotech environment
- Auditing experience
- Supplier Quality experience
- Working knowledge and understanding of ICH and global regulations to support regulatory intelligence
- Ability to work effectively in a team environment effective interpersonal and great organizational skills
- Regulatory Inspections experience
- Risk Management experience
- Working knowledge of Veeva and Redica systems or equivalent
- Ability to change the thinking of or gain acceptance from others in sensitive situations without damage to the relationship or the goals of the organization as this role regularly interacts with senior management or executive levels on matters concerning several functional areas
- Ability to lead and to interact and influence as an individual contributor
- Work Style of agility and nimbleness
- Ability to travel approximately 15
- 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.
- This position must be able to work East Coast hours.
Compensation and Benefits:
The expected salary range for this position is $138000 $180000. Actual pay will be determined based on experience qualifications location and other jobrelated factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
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 .
Required Experience:
Director
Employment Type
Full Time
