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Job Description
Within this role you will be responsible to work within the QA Change Control Team to primarily facilitate activities and relationships regarding External Manufacturing change controls.
As a Manager, a typical day might include, but is not limited to, the following:- Leading and managing direct reports, working to develop and oversee their performance and growth.
- Meeting with the External Manufacturing department to discuss changes for applicable products.
- Maintaining internal databases and tracking change notifications.
- Partnering with other members of the Quality Assurance team and/or end users of the system on the development and implementation of updates to the Change Control Process and associated procedures.
- Developing relationships with end users and providing advice on best practices/strategy for changes that require partner notification.
- Developing, monitoring and communicating metrics to ensure the health of the partner notification process.
- Partnering with counterparts to ensure global alignment of processes, systems and procedures.
- Partnering with colleagues in other departments on strategies to ensure changes do not impact supply.
- Assisting as needed in audits and inspections.
- Reviewing and approving Change Proposals as required.
This role might be for you if:
- You are knowledgeable in Biotech/Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory.
- You demonstrate the ability to perform independent work requiring attention to detail, accuracy, scientific judgment and a consistent record of shifting thought processes quickly from one task to another.
- You have the aptitude to comprehend, analyze and interpret process and systems information, technical procedures, reports and regulations to make decisions in a GMP environment.
- You demonstrate a proven track record of establishing and maintaining effective working relationships with managers and employees as well as influencing individuals of various levels to gain understanding and/or acceptance of an idea, policy, procedure or plan.
- You possess excellent interpersonal, written and oral communication skills with the ability to utilize active listening skills to understand concerns or reasoning in order to be responsive.
- You trust and build strategic relationships.
- You demonstrate proficient digital literacy in Microsoft (MS) Word, Excel, PowerPoint and SharePoint; Experience with Quality Management Systems heavily preferred.
To be considered for this position you must have a Bachelor's in a scientific or engineering discipline or related field with 8+ years experience in a combination of Quality, Production, Engineering, Regulatory (Chemistry, Manufacturing and Control) and/or Laboratory, with demonstrated accomplishments in effectively implementing cGMP requirements.
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