Project Manager-QA

• Drives departmental projects to completion through providing leadership and management to all personnel and functions involved. 

• Management of projects to meet appointed timelines and achievement of required completion dates, including large scale Quality initiatives in new technologies to improve efficiency. This involves migrations, transitions and implementations in varying electronic formats. 

• Assists and supports department in routine functions to include but not limited to deviation investigations, CAPA processing, and customer complaint investigations as needed. 

• Perform review and approval tasks for the department as needed. 

• Identification of project scopes, required resources, resource assignment and management.   

• Responsible for monitoring and updating project status and communicating this information to management. 

• Responsible for identification and resolution of roadblocks and streamlining where possible. 

• Responsible for communication and coordination with other departments to streamline the transition of projects to routine operation. 

• Provide leadership for ongoing projects. 

• Participates in departmental meetings and cross functional team meetings as required.  Assembles cross-functional teams and/or facilitates team meetings as necessary. 

• Assume the decision-making responsibility for day-to-day operations considering staff input and collaborating with other GB functions. 

• Provide scientific and/or technical advice and counsel regarding projects as needed. 

• Communicates company and departmental goals to the department’s exempt and non-exempt employees. 

• Manages large complex projects to bring in on budget, on schedule and technically correct by revising, analyzing and reporting the results against business parameters. 

• Communicates with cross functional departments and support groups to improve departmental performance and efficiency. 

• Maintain a quality presence to ensure compliance with all regulatory requirements. 

• Maintain current knowledge of regulatory and industry standards. 

• Strict adherence to procedures and practices according to FDA regulations. 

• Strong emphasis on documentation according to FDA regulations. 

REQUIRED EXPERIENCE/SKILLS & EDUCATIONAL QUALIFICATIONS 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. 

• Bachelor of Science degree in Engineering, Biology, Chemistry, Biochemistry, Information Systems or closely related scientific/technical discipline is required. 

• Minimum of 5 years direct Quality experience in a pharmaceutical, GMP, or FDA regulated environment is required. In addition, experience in quality assurance, quality control, quality operations, or engineering function is preferred.  

• Minimum of 3 years experience in SAP and Microsoft Access 

• Computer proficiency in MS Office (Teams, Outlook, Word, Excel, PowerPoint). 

• Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines. 

• Must have strong technical writing skills. 

• Demonstrated ability to inspire high performance in others and align team members around shared goals. 

• Demonstrated leadership skills with the ability to motivate, guide, train, coach and develop department personnel. 

• Demonstrated project management skills. 

• Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis. 

• Must be proactive, results oriented, and have strong attention to detail. 

• Self-starter with strong work ethic and the ability to exercise good judgment. 

• Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines. 

• Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment. 

• Excellent verbal and written communication skills in the English language. 

• Must be flexible with working hours / shifts in order to accommodate the 24 hour, 7 day plant operation. 

PHYSICAL REQUIREMENTS 

1. Ability to lift /move up to 50 pounds 

*This job description is accurate at the date of publication and may change over time.  It is not intended as an exhaustive description of the job.  Other duties may be assigned and qualifications required may change.