Sr. Director, Clinical Quality Assurance
100 Beaver Street Waltham, MA 02453 US
The Director/Sr. Director, Clinical Quality Assurance will be responsible for ensuring processes are conducted in accordance with guidelines and regulations with patient safety as the top priority. They will develop, perform, and manage clinical quality assurance activities and preside over audits.
The successful candidate will have a proven track record and hands-on experience building phase appropriate quality systems and a demonstrated ability to work in an early-stage, entrepreneurial environment. They will possess a “can-do”, execution-oriented mindset. This position will report directly to the Chief Development Officer.
Key Responsibilities and Opportunities:
As a key member of the Development Team you will:
- Work cross-functionally to lead the phase appropriate development, implementation, and ongoing improvement of our Quality Management System, including processes and procedures (SOP’s) to ensure clinical trials are conducted in accordance with all relevant guidelines and regulations.
- Nurture a strong, risk-based, quality compliance culture within the organization.
- Create, implement, and oversee audit plans for clinical trial sites, vendors, facility, and system audits. Effectively assess and communicate audit outcomes including major/critical compliance risks and potential short- and long-term impact of deficiencies to leadership and internal stakeholders.
- Lead/support the evaluation of quality events, incidents, queries, and complaints. Provide subject matter expertise and strategy to resolve GCP issues based on knowledge of regulations, guidelines and internal processes and procedures.
- Monitor and report on status of employee/contractor training
- Monitor and report on quality system effectiveness and quality assurance and compliance aspects of ongoing clinical activities to leadership and internal stakeholders.
- Be responsible for oversight of vendor qualification; maintain approved vendor list and their qualifications.
- Support compilation, writing, and review of regulatory submissions, clinical documents, safety documents, clinical trial materials etc. as appropriate.
- Lead preparations for regulatory inspections and ensure inspection readiness throughout course of all clinical trials.
- Manage extended team of consulting experts and contractors and identify on-going resource needs to deliver on strategic and operational priorities for the business.
- Keep up to date with all related clinical quality-related regulations and guidance as well as relevant industry and best practices.
- Bachelor’s degree in a science discipline (Biology, Chemistry, Biochemistry or similar) with at least 10 years of GxP Quality experience in the Biotech/Pharmaceutical Industry; including managing the QMS; at least 5 years of experience within Clinical QA.
- Thorough knowledge of all facets of GCP regulations, Quality Systems and Quality Risk Management to assure subject safety, data integrity, product quality (SISPQ) and clinical trial operational compliance.
- Proven skills and track record of building, leading, and developing Quality functions within the pharmaceutical or biotechnology industry
- Extensive experience with global clinical trial conduct
- Experience in preparing for and managing regulatory inspections, including dealing with compliance issues identified by regulatory authorities
- Proven ability in driving GCP process improvement initiatives
Personal Characteristics and Cultural Fit:
- Good judgement: Strong problem solving, critical thinking and analytical skills required to make evidence-based decisions. Good judgment, level-headed, neutral, and objective.
- Builds Relationships and Culture: Reputation for creating strong team cultures of quality, trust, and collaboration. Skilled at building and managing relationships cross-functionally and with external collaborators/partners, consultants, and vendors.
- Excellent written and oral communication skills
- Influences: Highly credible with various stakeholder group (internal employees up-down and across the organization, external collaborators, partners, and vendors and with site teams and investigators). Skilled at building and cultivating stakeholder confidence
- Execution mindset: Self-starter with a can-do mindset and do what is needed to advance the company’s programs and initiatives. Drives self, individual and team accountability, develops and implements goals, objectives, measurable targets, and processes to achieve results.
- Demonstrated ability to work in a fast-paced, innovative biotech environment.
Highly preferable to be based in the Boston area, or willing to relocate. Position may require travel (globally). Ability to travel up to 20%.
Salary range: $200-280k. Salary will be commensurate with experience
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