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