Quality Senior Manager
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Job Location:
Worcester, MA - USA
Monthly Salary:
Not Disclosed
Posted on:
1 hour ago
Vacancies:
1 Vacancy
Job Summary
About the Role: We are seeking a highly skilled Senior Manager to join our dynamic team supporting biologics regulatory this role you will serve as the lead author for key Module 3 Common Technical Document (CTD) sections. You will apply your analytical expertise and regulatory knowledge to deliver high-quality documentation in support of global regulatory submissions. You will be an integral member of cross-functional teams collaborating closely with Quality Control Quality Assurance Regulatory Analytical Research and Development and Chemistry Manufacturing and Controls (CMC) colleagues to deliver submissions to support commercial approval. The ideal candidate will have extensive analytical experience including authoring of analytical and stability regulatory submission sections a proven track record of excelling in a fast-paced environment and outstanding attention to detail.
Scope of responsibilities:
- Author and review new applications and amendments for CTD Module 3 sections S.2 S.4 S.5 and S.7 for regulatory submissions (e.g. BLAs MAAs INDs IMPDs etc). Support responses to regulatory questions and information requests.
- Provide subject matter expertise in analytical methods method validation reference standard qualification and stability studies.
- Ensure consistency accuracy and compliance of submission documents with current regulatory guidance and company standards.
- Remain up to date with regulatory requirements relevant to Module 3 content.
- Demonstrate the ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise to deliver results within project timelines.
- Proactively identify risks and propose solutions for documentation challenges.
- Lead cross-functional project meetings to support timelines and project deliverables.
- Interact and collaborate with teams to gather and interpret technical data.
Qualifications :
- Minimum Bachelors Degree required preferably in Chemistry Physical or Life Sciences Engineering or related subject; relevant advanced degree preferred.
- 8 years of combined experience in CMC Manufacturing QA QC R&D in pharmaceutical or biologics industry.
- 4 years of supervisory/technical leadership experience.
- Extensive authoring experience with Module 3 CTDs (specifically S.2.3 S.4.2 S.4.3 S.5 S.7) for regulatory submissions.
- Proven expertise in analytical/quality control laboratory or CMC regulatory environment.
- Strong understanding of global regulatory requirements and ICH guidelines.
- Demonstrated ability to work effectively on teams and build collaborative relationships across functions.
- Excellent written and verbal communication skills; attention to detail is essential.
- Self-motivated organized and capable of managing multiple priorities and deadlines independently.
- Must have a basic understanding and working knowledge of the physical and chemical characteristics of the products including raw materials manufactured at the plant.
- Must be familiar with use of statistical quality systems and electronic document management system.
- Must also be familiar with Quality policies as well as cGMP and other regulatory requirements.
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Continuous Integration
- Quality Assurance
- FDA Regulations
- Root cause Analysis
- TFS
- Food Processing
- ICH Q10
- Jira
- Software Testing
- Quality Management
- Selenium
- Github
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
