Manager, Quality Assurance
About the role
The Manager of Quality is responsible for supporting manufacturing, clinical and preclinical operations. This individual will be responsible for conducting audits of third parties, participating in the maintenance of a phase appropriate quality system, and the review of quality system and technical documentation. This individual will work closely with CMC, regulatory, clinical supply, clinical, preclinical, information technology and external CMO and CRO partners through all phases of drug development.
Responsibilities
- Plan, conduct and close out audits for third parties (e.g. CMO, CRO, and service providers) and maintain an approved vendor list
- Conduct internal GxP audits
- Maintain the quality management system to ensure adherence to applicable global regulatory requirements.
- Conduct batch record review (Executed and Master) for all phases of manufacturing (drug substance, drug product, packaging, labeling, and associated intermediates)
- Provide final disposition of finished product for clinical use, including country-specific release and collaboration with Qualified Persons (QPs)
- Author and review internal and third party deviations, CAPAs, and change controls
- Investigation of product complaints
- Review and approval of analytical and manufacturing documentation including analytical methods; analytical qualification protocol/reports; stability protocols/reports; and specifications
- QC of IMPD/IND CMC sections, as well as, clinical study documents such as protocols, IBs, etc
- Review of CRO preclinical and clinical study documentation
- Review and approval of clinical product labels
- Authoring, revising and reviewing SOPs to ensure compliance with regulatory requirements
- Implementation of process improvements
- Ensuring that GMP work at contract manufacturing organizations, GLP/GCP work at sites/CROs is done in compliance with applicable laws, regulations, guidelines, and SOPs.
- Participation in project teams and sub-teams as needed.
Required Qualifications
- BA/BS in science or engineering and a minimum of 7+ years of quality assurance experience in an FDA regulated Biotech or Pharmaceutical setting
- Working knowledge of GxPs (cGMP’s (CFR/ICH), GLPs, GCPs), and applicable international regulations/guidelines; with strong knowledge in CMC and GMPs
- Experience working in a virtual environment with Contract Manufacturing Organizations and Contract Research Organizations
- Experience in batch review and release for clinical phase products
- Experience reviewing manufacturing and analytical documentation
- Experience authoring and reviewing SOPs, Deviations, CAPAs, and Change Controls
- Experience working in Veeva
- Experience performing Quality audits.
- Ability to manage competing priorities and timelines in a fast-paced environment.
- Ability to problem solve
- Strong communication skills, both written and oral
This position is classified as exempt. The anticipated annual base salary range for candidates who will work in Watertown is $135,915 to $177,032. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, education, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.
Recruitment fraud statement
Please be aware of recruitment fraud and related job scams, where scammers present themselves as recruiters but are seeking to steal money or personal information. Keep the following in mind to protect yourself:
- Treeline Biosciences will never ask for money from you as part of our recruitment process. Do not provide bank details or pay somebody for the promise of a job at Treeline.
- We do not conduct interviews through Skype or Telegram.
- Our job openings are first posted to treeline.bio/careers. If you locate a listing for a Treeline job on another site, please ensure it is also posted on our careers website.
- You can find more information about job scams at consumer.ftc.gov/articles/job-scams.
- To report job scams, head to ReportFraud.ftc.gov.
The Human Resources team manages the recruitment and employment process for Treeline Biosciences. To protect the interests of all parties involved, Treeline Biosciences will only accept resumes from a recruiter if an executed search agreement directed to the particular position or positions is in place at the start of the recruitment effort. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.
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Treeline Biosciences Watertown, Massachusetts, USA Office
500 Arsenal St,, Watertown, MA, United States, 02742
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