The Manager, Quality Assurance (QA) is responsible for assisting in the development, coordination, and implementation of Good Clinical Practice (GCP) related quality assurance activities. These responsibilities include supporting the development, execution and maintenance of risk-based audit programs focused on internal and external GCP audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP guidelines, and MedSource policies and procedures. The Manager, QA oversees the tracking and trending of CAPAs and Deviations and manages and hosts sponsor audits as needed. Additional activities include assisting with the development of the inspection readiness program and providing regulatory inspection consulting and support as needed. The QA Manager is responsible for assisting in the development of departmental processes and procedures as well as reviewing and providing input on cross-functional processes and procedures. The Manager, QA promotes a GCP compliant environment with internal and external stakeholders while at the same time ensuring established MedSource Quality Management Systems are in place.
DUTIES AND RESPONSIBILITIES:
- Collaborate with the Director, QA to develop and implement the quality management system (QMS) for MedSource and establish quality goals and initiatives, risk assessments and ensure regulatory compliance.
- Work with the Director, QA to develop the MedSource audit strategy and implement inspection and audit readiness activities.
- Consult on the development of quality systems to support MedSource for process improvement and new business opportunities.
- Oversee the QA audit program, including development and maintenance of the company master audit schedule, audit plan development, oversight of auditors and/or consultants and endure deliverables meet quality standards. Additional duties include conducting and hosting of audits as needed and ensuring compliance with associated processes.
- Oversee client qualification, routine, and ad hoc audits as well as external qualification and ongoing audits of vendors and client partners.
- Assist with the management of the document control process, CAPA and deviations process, training program and initiatives and oversight of the vendor qualification/requalification process.
- Support concurrent clinical efforts by consulting on projects, representing quality assurance in interactions with customers.
- Ensure standard procedures are updated to reflect technological changes, regulatory trends, and best practices.
- Interface with regulatory agencies, clients, internal and external stakeholders, and vendors, as needed.
- Support company regulatory GCP inspections and serve as the liaison to the Food and Drug Administration (FDA) and other regulatory agencies.
- Foster an environment that supports compliance and drive continuous improvement activities with emphasis on root cause analysis.
- Work with the Director, QA to establish, maintain, and distribute metrics (process capability, control charts, measurement quality) for monitoring quality system effectiveness.
- Evaluate new and changing regulations to minimize risk(s) that impact MedSource.
- Identify and develop resources required to support needs and requirements to maintain compliance.
- Advise/coach/train staff to ensure compliance with internal and external policies, laws, and regulations.
- Achieve financial objectives by preparing the QA budget, scheduling expenditures, analyzing variances, and initiating corrective actions.
MINIMUM JOB REQUIREMENTS / QUALIFICATIONS:
- Minimum requirement of a Bachelor’s Degree or equivalent combination of experience and education in a scientific discipline is preferred.
- At least 5 years of relevant QA experience and increasing responsibility in the Biotech/Pharmaceutical Industry in a GCP quality role.
- GCP Auditing experience required and participation in regulatory inspections in highly desired.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
- Demonstrate in depth knowledge of the drug development process (early through late stages), trial design, data, and trial management procedures.
- Ability to compile and interpret quality metrics.
- Strong working knowledge of regulatory requirements and GCP guidelines and ability to apply them in daily practices.
- Excellent verbal and written communication skills with the ability to work well in teams or independently and able to prioritize work, manage multiple projects and personnel while maintaining quality work.
- Strong analytical and writing skills to identify issues, solve problems and document them appropriately.
- Strong organizational and project management skills, attention to detail, and professionalism required.
- Ability to manage and coordinate multiple projects and assignments in a demanding fast-paced environment with changing priorities and activities.
- Ability to work with others as part of a collaborative team and negotiate effective solutions; strong interpersonal and social skills.
- Consistently exercises discretion and independent, sound judgment in the performance of the duties described above.
- Computer literacy in Microsoft Office Suite (MS Word, Excel and PowerPoint).
- Requires a highly motivated, resourceful, creative, decisive self-starter that can set goals, shift priorities, and work collaboratively to ensure regulatory compliance and high-quality results.
CONDITIONS OF EMPLOYMENT:
Verification of educational requirements, employment history, professional references, and certifications/training.
WORKING CONDITIONS AND PHYSICAL EFFORT:
- Work is normally performed in a typical interior/office work environment
MedSource is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.