We are currently looking to fill a Manager, Quality Assurance position on the Quality Assurance Change Control Team. This role works within the QA Change Control Team to facilitate cross-departmental best practices in change evaluation, ensure smooth facilitation of change control activities, and support the global team.

As a Manager, Quality Assurance, a typical day might include the following:

• Developing and facilitating best practices for QA departmental change evaluations

• Sponsoring and advocating for Continuous Improvement activities and working with other members of the Quality Assurance team and/or end users of the system on the development and implementation of updates to relevant processes

• Developing relationships with end users and providing advice on best practices/ strategy for departmental change evaluation

• Developing, monitoring, and communicating metrics to ensure the health of the Change Control System

• Ensuring support infrastructure fills the needs of QA and end users across IOPS sites.

• Partners with counterparts to ensure global alignment of processes, systems, and procedures

• Interpreting compliance and regulatory requirements for incorporation into departmental systems, procedures, and documentation.

• Assisting as needed in audits and inspections

• Responsible for leading, mentoring and developing direct reports.

This role might be for you if:

• Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory

• Demonstrated 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

• Aptitude to comprehend, analyze and interpret process and systems information, technical procedures, reports and regulations to make decisions in GMP environment

• 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

• Proficient digital literacy in Microsoft (MS) Word, Excel, PowerPoint, and SharePoint required. Experience with Quality Management Systems heavily preferred

To be considered for this role you must hold a BA/BS degree in life sciences discipline or related field (chemistry, biology, or pharmacy preferred) and the following minimum amounts of relevant experience for each level:

• Manager – 7 years

• Senior Manager – 8 years

Experience preferred in pharmaceutical or biologics manufacturing environment, including some supervisory and/or leadership experience. May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

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