Sr. Manager, Quality Assurance, Systems and Compliance
6 days ago
Sr. Manager, Quality Assurance, Systems and Compliance
6 Month Initial Contract (can extend up to 18 months)
Norwood, MA (on-site)
MUST HAVE
- Bachelor’s degree
- 10+ years of experience in Pharma providing QA oversight in a cGMP organization (oversight=managing performance and effectiveness of the QMS programs including risk management, change management, discrepancy and CAPA management, training, documentation and records management, and data integrity)
SUMMARY
Exciting opportunity to be a part of a growing Quality Assurance organization, with a state-of-the-art cGMP manufacturing facility in Norwood, MA, USA. The site focuses on manufacturing early phase and commercial product. As the company grows, Quality Assurance is looking for talented individuals with a strong Quality Culture mindset and ability to adapt to a fast-paced environment. This role will be supporting many of the responsibilities listed below and will be expected to collaborate with cross-functional departments to maintain and enhance compliance at the Norwood site. We work collaboratively as a team, boldly strive for excellence, are constantly curious and committed to ongoing learning and improvement, and relentless in our pursuit of having the highest level of Quality products.
Responsibilities
- Manage the performance and effectiveness of the quality system programs such as risk management, change management, discrepancy and CAPA management, training, documentation and records management, and data integrity via maintenance and execution of Quality Management Review and Site Quality Council governance forums.
- Support the establishment and reporting of quality metrics for cGMP related functional areas.
- Author and review SOPs and Policies to ensure compliance and adherence to regulations/cGMP operations.
- Author, review, and approve Annual Product Quality Reviews (APQR) and other trend reports.
- Partner cross-functionally to maintain a company culture that embraces compliance and recognizes that compliance is a collective responsibility of all company employees.
- Continue to improve XXX overall Quality Management System (QMS) and quality manual, policies and procedures while keeping them current with emerging and changing regulations, guidance documents and current industry best practices and expectations.
- Provide compliance guidance and training through various methods including formal and informal presentations and trainings.
- Identify opportunities for quality system improvements.
- Work collaboratively with the digital team on the GXP integrated digital landscape to support eDOC, eQMS, and LMS systems.
Education & Qualifications | Required
- Bachelor’s degree with a minimum of 10 years of experience in the pharmaceutical industries providing Quality Assurance oversight in a cGMP organization.
- Fluent in written and spoken English.
- Experience in data analysis, statistical evaluation, and trending of data.
- Ability to think critically and demonstrate troubleshooting and problem-solving skills.
- Understanding and experience with global cGMP regulations (e.g. FDA, MHRA, EMA, PMDA, ANVISA) and ICH guidelines.
- Ability to interact effectively with all levels of personnel within the organization.
- Ability to navigate through ambiguity and rapid growth and adapt to change.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Preferred
- Master’s degree with a minimum of 8 years of experience in the pharmaceutical industries or Ph.D. with a minimum of 5 years of experience in the pharmaceutical industries providing Quality Assurance oversight in a cGMP organization.
- Deep understanding and experience with global cGMP regulations (e.g. FDA, MHRA, EMA, PMDA, ANVISA) and ICH guidelines.
- Advanced experience in data analysis, statistical evaluation, and trending of data.
- Capability to lead and train a diverse, multinational community of practice with multiple stakeholders.
- Proven ability to lead and manage projects/teams of significant scope and complexity, meeting deliverables and timelines (project management skills).
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Norwood, United States Randstad Life Sciences US Full timeSr. Manager, Quality Assurance, Systems and Compliance6 Month Initial Contract (can extend up to 18 months)Norwood, MA (on-site)MUST HAVEBachelor’s degree 10+ years of experience in Pharma providing QA oversight in a cGMP organization (oversight=managing performance and effectiveness of the QMS programs including risk management, change management,...
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