The Manager, Quality Assurance will be responsible for managing the Quality Assurance group within a division of Bracket.
Essential Duties and Responsibilities:
Note: Other duties may be assigned.
Assists in the development, revision, application, maintenance, validation and review of quality standards, documents, investigations and follow up corrective actions to assure compliance with Bracket Quality Policies
Implements, maintains, and/or improves quality systems to meet or exceed regulatory compliance through the internal audits program
Assists with the implementation of the on-going internal audits program, including conducting and tracking remediation activities related to audit outcomes
Manage the process of on-site Sponsor and Regulatory Audits
Reports and monitors audit findings and action items with department managers
Measures and reports on internal compliance activities in a regular forum
Assists Bracket employees with various process improvement efforts from a quality process perspective on an as-needed basis
Maintain current knowledge of FDA regulations and guidance and offer training, as appropriate.
Participate on Information Technology and Product Innovation development project teams as QA representative
Serve as an escalation point for quality related issues that cannot be resolved directly by team members, project managers, software developers, etc.
Set expectations and monitor the QA team’s/individual’s work.
Ensure that QA individual and team commitments are met. Monitor performance against targets.
Liaison with key stakeholders, cross-functional managers and peers around personnel issues to ensure effective and motivated staff and a strong relationship with other teams.
Actively coach and mentor QA team members, provide constructive feedback and suggestions for improvement.
Other project work and responsibilities as required.
Skills & Competencies
At least 3-5 years of quality assurance experience, including prior auditing experience in the pharmaceutical and/or software industries.
Knowledge of the clinical trials process, FDA regulations and ISO quality principles.
Prior experience working in a software development environment.
Competencies & Personal Attributes
Strong organizational, time-management, analytical and decision-making skills.
Strong verbal and written communication skills, including the ability to positively influence the behavior and performance of staff and to positively impact the decision-making of staff, peers and superiors.
Strong supervisory, training, coaching/mentoring, team building, facilitation and leadership skills to fully equip/engage staff to accomplish work goals in a fast-paced and changeable work environment.
Ability and willingness to travel domestically and internationally as required.
Ability and willingness to work non-standard business hours as business needs dictate.
We offer a highly competitive base salary and an outstanding benefits program, including medical, prescription drug, dental, vision, 401(k) with Company match, life insurance, and generous paid time off.
We are an Equal Opportunity Employer, M/F/D/V