Senior Specialist, Quality Assurance - Menlo Park
Menlo Park, California, United States
Location: Menlo Park, CA
Reporting to: Associate Director, Quality Assurance
Orchard Therapeutics, Ltd. is a biotechnology company incorporated in September 2015 and dedicated to bringing transformative gene therapies to patients with serious and life-threatening rare diseases. This an exciting opportunity for a well-qualified candidate to join a rapidly growing international company focused on transforming the lives of patients through innovative gene therapies.
The Orchard team based in Menlo Park is in an exciting start-up phase where a Sr. QA Specialist can have a real impact on the work and foundations that are being created. This role will report directly to the Associate Director of Quality Assurance and will be a key asset in the growth of the Quality Department. This opportunity is unique due to the size of the team and exposure that the successful candidate will have to senior management and key decision makers.
- Review and approve master batch records, master labeling/packaging records, product specifications and other process related documents from contract sites.
- Perform batch record and data review/approval and manage process deviations for timely release.
- Review and/or approve deviations, OOSs, CAPAs, change control in an efficient manner for adequate and timely closeout of these events.
- Write, revise, and periodically review SOPs to further develop the Quality System and control over the quality of vendor services and products.
- Review and approve manufacturing validation protocols and reports.
- Review and approve Equipment Qualification and Software Validation documents, including but not limited to requirements or specification documents, FMEA, and IQ/OQ/PQ protocols and reports.
- Review and approve product stability reports.
- Assist in the QC review of various documents, including regulatory dossiers, reports, and raw data.
- As appropriate, attend project meetings and provide input to quality-related issues.
- Clearly communicate issues to vendors and Orchard Therapeutics management in a timely basis.
- Support regulatory inspections; internal and external
- Support activities at CMOs ensuring compliance with CGMPs and Orchard Therapeutics best practices.
- May assist in the development and tracking of Quality metrics. May prepare metrics for the Management Review and Annual Product Review
** Other functions may be assigned.
- Strong technical/analytical skills to identify and solve problems.
- Self-motivated, assertive, and self-confident with the ability to act with urgency and passion.
- Proven ability to work with both internal and external stakeholders.
- Proven ability to work with a high level of integrity, accuracy, and attention to detail.
- Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time.
- Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.
- Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions.
- Demonstrated negotiation skills.
- Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strength decision-making.
- Proactively seeks out and recommends process improvements.
- Resourceful, creative, enthusiastic, and results-oriented.
- Entrepreneurial, enjoys working in a fast-paced, small-company environment.
- Bachelor’s degree in scientific discipline such as chemistry, biology or equivalent
- Working knowledge of US and EU CGMPs
- 5 years of experience in the pharmaceutical/bio-pharm manufacturing industry
- 3 years of experience in cGMP Quality Assurance
- Experience working with Quality systems in support of both early and late stage development programs
For further information on this role do not hesitate to email email@example.com
The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plans. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k). Orchard Therapeutics is an equal opportunity employer.
Notice to All Applicants: Orchard Therapeutics participates in E-Verify
Notice to RECRUITERS: All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.