Associate Director, Quality Systems & Compliance
Posted on Apr 5, 2021 by Akcea Therapeutics, Inc.
This position will report to the Director of Quality Management Systems and will assist in the responsibility of supporting and ensuring current good practice regulations (GxP); including current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), and Good Pharmacovigilance Practices (GVP), have been met throughout the development and commercial life cycle of Akcea products.
The successful candidate will be able to ensure internal and external compliance to Akcea Standard Operating Procedures and current industry standards and practices have been met throughout the development and commercial life cycle of Akcea products, under the guidance of the Head of Quality.
Manage processes and SOPs in the area of responsibilities (Deviations/Investigation, CAPA, Quality/Operational Risk Management, Change Control, Quality Metrics, Internal Audits, External Vendor Audits, and Inspection Readiness).
Partner with and influence key personnel in Akcea's Organization to align and facilitate harmonization of strategy, procedures, and processes.
Manage the Inspection Readiness Program and oversee the execution of regulatory audits and tracking of responses to ensure progress. Compiles all regulatory inspection observations/findings and monitor for signals and trends.
Manage the Internal and External Audit Schedules/Programs and oversee the execution of the remediation responses to ensure progress. Compiles all audit findings and monitor for signals and trends.
Manage the Vendor Management System, which includes the vendor approval and qualification process, maintenance of the Approved Vendor List, and oversee the management for creation/response to vendor questionnaires.
Establish and manage the Akcea Risk Register process/program as a means of ensuring appropriate levels of identification, investigation, escalation, and resolution of quality issues for communication to the appropriate level of management and governance within Akcea.
Coordinate and manage the Quality Council Team (QCT) Review meetings, including the generation of quarterly QCT reports.
Establish and monitor quality metrics for GXP related functional areas within the organization. Issue monthly reports. Escalates significant issues to executive management, as required
Assist in the management and logistics of third-party inspection related activities.
Identify quality issues/discrepancies, and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner.
Promote a quality mindset within Quality and throughout Akcea by ensuring consistent, risk-based, and innovative thought processes are employed to advise and make decisions.
Communicate milestones and planned changes to the user community regarding Quality System and Compliance initiatives.
Participate in user forums/industry groups (such as; Pharmaceutical Drug Association - PDA) to garner best practice and champion those initiatives within Akcea
Leads/participates in projects related to the general area of QA's responsibilities
BS (required), MS (preferred), degrees within a STEM (Science, technology, engineering or mathematics) discipline
Pharmaceutical/biotechnology industry experience (10+ years) with at least 7 years in a Quality function.
Expertise in the US (ISO-13485, ISO-14971, etc.) and EU cGMP guidelines (ICH Q7, Q8, Q9, Q10) and other international regulatory requirements.
Strategic experience with senior leadership team level clients, strong decision-making capability.
Strong leadership and management experience with the ability to work in a Matrix environment
Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
Excellent written and verbal communication skills and proficiency in Microsoft software applications including Word, Excel, Visio, PowerPoint, Outlook, and SharePoint
Strong knowledge of Veeva Vault applications
Expert knowledge and experience with data analysis, reporting, and trending.
Proven success in identifying and implementing organization-wide operational excellence/improvement initiatives.
Demonstrated ability to work across functions at all levels where the incumbent may not have direct authority to accomplish objectives.
Extensive Risk management experience (FMEA, REM, PHA, etc).
Project management experience including essential skills to lead cross-functional teams.
Demonstrates initiative; ability to undertake additional responsibilities and respond to situations as they arise with little or no supervision.
Ability to make independent sound decisions and independently manage priorities in alignment with department and site drivers.
Ability to work and communicate with all levels within the organization constructively and positively.
Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
Must be a dynamic, hands-on manager with a clear practical understanding of GXPs and the ability to support regulatory inspections, as required.
Must be able to manage problems of diverse scope using a high degree of personal judgment and must be able to effectively represent Akcea' Quality Systems and Compliance programs to internal stakeholders and external regulatory agencies.
Strong interpersonal skills particularly motivational, negotiation, listening, judgment, and conflict management skills, demonstrated by the ability to lead teams in matrixed environments.
Excellent organization, verbal, and written communication skills with the ability to effectively promote and manage change.
Ability to effectively mentor and develop staff.
Ability to effectively interface with internal customers, 3rd-party partners, and regulatory agencies.
Problem-solver with the ability to make difficult decisions under challenging circumstances