Manager Quality Compliance (Change Control External Manufacturing)

We are currently looking to fill an Associate Manager Quality Compliance position on the Quality Assurance Change Control Team.

This role works within the QA Change Control Team to primarily facilitate activities and relationships regarding External Manufacturing change controls.

As an 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 of 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

Demonstrate the ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a consistent record of shifting thought processes quickly from one task to another

Have the aptitude to comprehend, analyze and interpret process and systems information, technical procedures, reports and regulations to make decisions in GMP environment

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

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, gain trust and build strategic relationships

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.

Experience in change control function strongly preferred. Level is determined based on qualifications relevant to the role.

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