Quality Assurance (GxP) Manager/Associate Director

At Koneksa, we are focused on using new technologies to improve clinical research and drug development. We help leading life sciences companies and research hospitals remotely capture real-world data from patients. Our projects deploy digital health technologies such as FDA approved activity trackers, wearable vital sign monitors, and other emerging monitoring devices that collect data outside the clinical and laboratory setting. We are developing digital biomarkers that help our customers make faster decisions, often using smaller studies, with technologies that enhance the experience of the patients who participate.

We're on a constant quest to improve the tools and endpoints that are used to get the right new therapies to patients who need them. Our experienced and diverse team challenges traditional development paradigms to work at the intersection of what some would consider competing forces—compliance and innovation. At Koneksa, we believe that science, technology, analytics, and agile learning experiences are primary drivers to develop patient-centric solutions that enable our customers to make faster decisions in clinical trials.

The Quality Assurance Manager will be responsible for managing the day-to-day operations of the Quality Management Systems (QMS), metrics and trending reporting for GxP Internal Audits, Vendor Audit management, Deviations, CAPAs, Effectiveness Checks, Change Control, Product Complaints. Additionally, the Manager will partner with internal departments to develop and support QMS process improvement implementations that meet business and regulatory requirements.

Responsibilities

• Manage the Quality Management Systems (QMS) program (i.e. Deviations, CAPAs, Product Complaints, Change Controls, Vendor Management, External Audits, and Internal Audits).

• Support implementation of continuous improvement of QMS

• Develop Vendor re-qualification and Internal Audit schedules, manage External Audit/Assessment expectations and perform reconciliation activities for each area.

• Monitor the performance of the Quality Management System. This includes creation of metrics for tracking compliance to established quality standards, monitoring the effectiveness, and supporting continuous improvements.

• Collaborate and assist GxP business partners in incident evaluations, investigations, risk assessments, management, and remediation as a compliance lead as needed.

• Plans, directs, and coordinates implementation of Quality/Compliance program activities including the creation/ revision of controlled documents (e.g., SOPs, policies) in accordance with cGXP regulations and internal standards.

• Works with Koneksa personnel to design and implement programs to improve overall quality and increase regulatory compliance.

• Ensures GXP documents (SOPs, deviations, changes, validation reports, etc.) are reviewed for completeness, accuracy, and conformance to GXPs.

• Act as a contact with clients.Regulatory Authorities and / or vendors; assist and lead inspections / audits, in agreement with QA management.

• Monitors changes and amendments to the applicable regulations (e.g., CFR, ISO standards for devices, FDA guidance documents, EU GMPs) to ensure that Koneksa’s procedures are compliant and current.

• Monitors and trends key quality and compliance metrics for Konkesa and suppliers; reports adverse trends to management with remediation plan.

• Assist in identifying and resolving compliance issues at internal and external sites; provide assessment of the impact of any deficiencies.

• Supervises, trains and mentors staff to perform quality functions consistent with GxP requirements.

• Participates in project meetings and compliance initiative teams, to provide the compliance/quality perspective and technical support as needed.

• Ensures that the appropriate validations are enacted on time and documented.

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  Undergraduate degree preferred - equivalent work experience will be accepted in a life sciences discipline with a minimum of 8-10 years of pharmaceutical/biotechnology experience and managing/administering a QMS or another Quality System.

• Experience working in an electronic Quality Management System

• Working knowledge of 21CFRPart11 and computerized systems regulations

• Experience in Metrics generation

• Auditing experience is required.

• Excellent communication, collaboration, partnership, influencing and negotiation skills.

• Project management skills and demonstrated ability to coordinate and manage projects with multiple functional groups.

• Strong attention to detail, strong compliance mindset, and strong written and verbal communication skills.

• Ability to effectively prioritize work and assess risk of issues.

• Proficient with root Cause Analysis, technical writing for investigations, development, and implementation of CAPAs

• Experience facilitation of training material to end users

• Experience assessing risk and applying prioritization principles to identified risks

All your information will be kept confidential according to EEO guidelines.