Senior Director Quality Assurance Curemark New York City

Job Description
With a Phase III trial well underway, plans for other clinical trials in the works and a strong pipeline of preclinical and clinical candidates – Curemark is the perfect opportunity for a Quality Assurance professional who is excited about designing and building a robust Quality Assurance program. You have deep experience in this area from a pre-clinical, but more importantly from a clinical perspective. You know what it means to be in a start-up environment and you aren’t afraid to roll-up your sleeves and get the work done!
As our QA Director, you can balance maintaining a “big picture” perspective without losing sight of the details and the deliverables. Quality is important, but you believe that fostering a positive work environment, teamwork and trust are equally important. Your interpersonal skills are outstanding and you have the ability to influence individuals and teams across the organization in the absence of a direct reporting relationship.

Responsibilities:



Oversight and leadership of the clinical and commercial quality systems areas at Curemark and responsibility for meeting compliance and quality assurance requirements for commercial pharmaceutical manufacturing.



• Effectively employ the principles of ICH Q9 (Risk Management) and ICH Q10 (Pharmaceutical Quality System)

• Develop and lead a Risk Based Quality Management System.

• Build and maintain a robust quality program that will effectively support commercial manufacturing.

• Administer commercial quality systems including:



Deviation
CAPA
Change Control
Vendor Management
Training
Internal/External Audits
Document Control
Quality Management Review
Annual Product Review
Product/Customer complaints


• Quality Oversight of Contract Manufacturing Organizations including:

Auditing
Deviation/Change Control
Batch Record Review
Batch Release


* Provide support as necessary to ensure GMP readiness, quality related projects and issues/concerns.

* Conduct ongoing evaluations of quality programs, systems and initiatives to assure that product quality standards and regulatory compliance are achieved

* Develop and implement effective quality programs aligned with corporate strategic initiatives and business goals.

* Interpret Regulatory Authority regulations, guidelines and policies; utilize internal audits and quality compliance assessments programs to evaluate Curemark’s processes and procedures.

* Conduct regular risk assessments to ensure processes and procedures are in compliance with cGMPs.

* Appropriately resource regulatory inspections.

* Author and direct the approval of the Quality Manual, Quality Policies, Protocols, SOPS, Batch Records, Test Methods, Raw Material Specifications, and Annual Product Reviews, especially within an outsourced CMO model

* Provide Quality expertise as needed for Deviations Reports and Out-of-Specification Reports.

* Ensure that manufacturing processes, equipment, facilities and systems are validated and that a robust Change Control system and procedures are developed and maintained to meet state, federal, and international requirements.

* Ensure that suppliers and contract manufacturers are operating in compliance with state, federal, and international GxP regulations and guidelines through an external audit program.

* Develop a team, when appropriate, to establish and maintain efficient and effective Quality Systems and programs.

* Develop operational budgets, cost controls, cost estimates, capacity and resource plans as well as facility requirements to support corporate strategic business objectives.

* Communicate and ensure compliance of corporate Quality objectives, policies and procedures.



Qualifications:



* BA/BS in a relevant scientific discipline and a minimum of 8+ years industry experience with significant management experience providing both strategic and leadership guidance to an organization in quality assurance.

* Must have a quality background from the biotechnology/pharmaceutical industry with GMP experience and a successful track record in quality within FDA and/or EMEA regulated environment.

* Experience in quality management and compliance systems

* In-depth knowledge of QA Document Control, GXP compliance, and QA Auditing

* Experience in development QA associated with pre-clinical and clinical development and commercial products.

* Execution-oriented philosophy with proven ability to develop and implement operating plans from strategic business and project plans.

* Demonstrated leadership in cross-functional and culturally diverse team settings.

* Able to work collaboratively in a matrix structure while ensuring that timelines and deliverables are met

* High energy, enthusiasm and excellent leadership and management skills

* Excellent oral and communication skills

* Strong leadership and experience in managing diverse personalities and functions to achieve successful integration of the team with positive results.