Director, Quality Assurance - Hybrid

** Job Description*
* The  
** Director, Quality Assurance
** will be responsible for team leadership and technical subject matter expertise in Sterile Drug Product Quality Operations at our Company's Rahway, New Jersey site.  This position will serve a critical role in supporting the expansion of clinical development activities at the site with responsibilities including, but limited to the following:

+ Execute GMP quality assurance activities directly related to sterile drug product production and release for clinical trial material supply.

+ Support the start-up of a new, state-of-the-art sterile filling line.

+ Support the design and operational readiness of multiple other significant capital projects that are aligned with the expanding site mission.

+ Develop relationships with and provide Quality oversight of key partner groups that are commensurately expanding in size and scope of work.

+ Lead and develop a growing team of professionals.

The successful candidate will assure that quality systems and controls for investigational new drugs (investigational medicinal products) meet all quality requirements, regulatory standards, and meet continuous clinical supply and delivery expectations.

*
* Essential Duties and Responsibilities:

*
* + Lead and perform quality assurance activities (e.g., review and approve GMP documentation) related to internally and externally sourced sterile drug products in a complex and rapidly changing clinical development environment.

+ Support sterile drug product manufacturing in compliance with cGMP, regulatory expectations, and clinical filings.

+ Provide Quality oversight of formulation, process and analytical development activities

+ Provide Quality oversight of investigations of events or deviations to support batch release and facility control decisions.

+ Enable ongoing start-up of a new, state-of-the-art sterile filling line.

+ Support evaluation, introduction, and installation of new processes, technologies and capabilities.

+ Support design and operational readiness of sterile manufacturing facility expansion.

+ Build effective, collaborative working relationships and create effective communications within and across organizations and with all stakeholder functions and levels.

+ Identify improvement/efficiency opportunities and propose and implement appropriate solutions.

+ Provide a Quality mindset while balancing operational needs to develop pragmatic solutions to complex, technical and compliance challenges.

+ Support activities necessary to achieve GMP compliant and continuous clinical supply.

+ Serve as steward for knowledge management and capability build within team.

+ Manage program assignments and facility coverage.

** Education Minimum Requirement:*
* + Bachelor's degree in science, engineering, or related discipline; an advanced degree will be preferred.

** Required Experience, Knowledge, and

Skills:

*
* + Minimum of 12 years of experience in Pharmaceutical / Biotechnology industry role(s).

+ Experience in Quality and manufacturing operations of sterile drug products, at pilot and/or commercial scale.

+ Strong knowledge and application of Current Good Manufacturing Practice (cGMP) for sterile product manufacturing (e.g., Annex
1) and the application of Quality Risk Management principles.

+ Technical understanding and knowledge of manufacturing processes and unit operations for sterile and/or large molecule products.

+ Leadership of cross-functional teams, investigations, or problem-solving situations.

+ Interpersonal skills in verbal and written communications, collaboration, teamwork, negotiation, and conflict resolution.

** Preferred

Experience and Skills:

*
* + A combination of experiences in sterile product formulation, development, process development, manufacturing, technology transfer, scale-up, facilities, quality systems, and / or quality operations

+ Advanced technical knowledge in one or more elements of sterile products, processing, sterile dosage forms and associated technologies.

+ Advanced ability to identify and solve complex problems in a timely and efficient manner.

+ Experience in R&D or clinical supply areas and processes

+

Experience with leading, growing and developing teams

+

Experience with facility design and start-up

EligibleforERP

*
* Required Skills:

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* Capital Projects, Capital Projects, Change Management, Clinical Development, Clinical Trials, Coaching, Collaborative Communications, Conflict Resolution, Data Integrity, Decision Making, GMP Compliance, Interpersonal Communication, Interpersonal Relationships, IS Audit, Leadership, Leadership Training and Development, Manufacturing Processes, Manufacturing Quality Control, Operational Efficiency, People Leadership, Quality Assurance (QA), Quality Auditing, Quality Management Standards, Quality Risk Assessment, Quality Risk Management {+ 5 more}

** Preferred

Skills:

*
* Current Employees apply HERE ($6687.htmld)

Current Contingent Workers apply HERE ($4020.htmld)

** US and Puerto Rico Residents Only:*
* Our company is committed to…