Hybrid Sr. Manager/ Associate, Director, GMP Quality Assurance bei Gossamer Bio
Gossamer Bio · San Diego, Vereinigte Staaten Von Amerika · Hybrid
- Junior
- Optionales Büro in San Diego
SUMMARY
The Sr. Manager/ Associate Director of GMP Quality Assurance will be responsible for quality oversight for GMP activities to support third party manufacturing, packaging, testing, and supply of drug substance and drug products for use in clinical and commercial operations. Manage batch record review, product investigations, deviations, complaints, change control, and other actions related to GMP activities, as required. They will review internal and external documentation for compliance with established standards and regulations. Provide input as necessary into the review and establishment of product specifications and GMP related SOPs. Collaborate with cross functional team members and support Gossamer GMP activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Review and approval of manufacturing release testing and stability batch records for compliance
- Evaluate, review and approve change controls, GMP investigations and deviations.
- Review of Quality Agreements with contract manufacturers.
- Review and approve master batch records, risk assessments, methods, specifications, and validation protocols and reports.
- Review and assess specifications, reference materials and test results.
- Provide quality oversight of process and method transfer/validation and activities
- Conduct and support GMP audits and internal audits as needed
- Gather quality metrics, supporting and/or participating in quality management review.
- Review and update GMP related SOPs and policies
- Serve as QA representative on departmental and project team(s) representing CMC Quality.
- Work across departments and with contract manufacturers to ensure readiness for regulatory inspections and participate in inspections as needed.
- Provie input into the operating budget for the GMP QA function.
- Communicate and promote a culture of quality and operational excellence.
- Effectively represent Quality to regulatory agencies.
- Maintain current knowledge and full understanding of compliance and regulatory
- requirements (FDA, EMA, MHRA, etc.) related to the manufacture of active pharmaceutical ingredients and drug products.
Data Privacy
- Work as part of cross-functional teams to advance a strong and mature data privacy and data protection program across the company, including key vendors and third-party providers
JOB QUALIFICATIONS
Education, Certifications, Experience
- Bachelor's degree in relevant scientific discipline is required. An advanced degree is preferred.
- 10+ years of relevant experience in the area of GMP quality assurance in the pharmaceutical industry with at least 2 years in a managerial/leadership capacity
Knowledge, Skills and Abilities
- Significant hands-on experience with small molecule drug development in a biopharmaceutical company.
- Extensive knowledge of US cGMP compliance regulations and industry practices, as well as EU GMP requirements.
- Ability to critically evaluate and troubleshoot complex problems and attention to detail.
- Strong leadership and management skills.
- Excellent interpersonal skills with the ability to effectively interact with and influence different functional groups at all levels of management.
- Excellent verbal and written communication skills.
- Ability to manage multiple priorities and aggressive timelines.
SPECIAL WORKING CONDITIONS
- Office environment / Domestic and International travel up to 25% may be necessary
Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.
The expected salary range for this position based on the primary location in California is $165,000 to $200,000. Actual pay will be determined based on experience, qualifications, geographical location and other job-related factors permitted by law. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below:
Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching , long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit https://www.gossamerbio.com/careers-culture/who-we-are/
California Consumer Privacy Act (CCPA) Notice for California Residents:
This notice is to notify you that personal data about you has been collected by Gossamer Bio (“Controller”), which is located at 3115 Merryfield Row, Suite 120, San Diego CA 92121 and can be contacted by emailing [email protected], because Controller wishes to evaluate your candidacy for employment at Controller.
Your personal data was either obtained from publicly available sources (e.g. LinkedIn) or provided to Controller by someone who referred you for potential employment. Controller’s Privacy team can be contacted at [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) and the California Consumer Privacy Act (CCPA) 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 has been 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.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR and CCPA, 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 a supervisory authority.
