Associate Director - Quality Assurance

Job Description The Associate Director, Quality Assurance will be responsible for quality leadership and subject matter expertise in Quality Operations, Facilities and Validation, and Low Bioburden facilities at the our company Rahway, New Jersey site.  This position will serve an important role in supporting the expansion of clinical development activities at the site with responsibilities including, but not limited to the following:

Execute GMP quality assurance activities directly related to facilities, equipment, and automation for clinical trial material supply capabilities.

Support the design phases and operational readiness of one or more cross-modality capital projects that are aligned with the expanding site mission.

Drive quality from design through qualification, start-up, and operations of new facilities as well as maintain and sustain existing operations and facilities.

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

Participate in a growing team of professionals enabling an expanding site asset base.

The successful candidate will assure that quality systems and controls for investigational new drugs (investigational medicinal products) meet all relevant our company quality requirements and regulatory standards.

Essential Duties and Responsibilities:

Manage projects and tasks affiliated with Quality oversight of GMP facilities.

Lead and perform quality assurance activities related to qualification and validation of facility, equipment, and automation assets in a complex and rapidly changing clinical development environment. Assure compliance with cGMP, regulatory expectations, and clinical filings.

Provide Quality oversight of GMP processes, including calibration, qualification, validation, change management, quality risk management, batch record review, and quality investigations.

Enable the capital asset lifecycle through phases from design through start-up to deliver and sustain compliant manufacture & testing of clinical trial material.

Build effective, collaborative working relationships and create effective communications within and across organizations.

Identify efficiency opportunities; propose and implement value added solutions.

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

Ensure current industry best practices and benchmarks are applied to design and implementation of new GMP facilities and equipment.

Education Minimum Requirement:

Bachelor’s degree in science, engineering, or related discipline; an advanced degree is preferred.

Required Experience, Knowledge, and

Skills:

Minimum of 8 years of experience in Pharmaceutical / Biotechnology industry role(s). Experience in Quality, Operations, and/or related functions at pilot and/or commercial scale. Strong knowledge and application of Current Good Manufacturing Practice (cGMP). Working knowledge of capital projects and facility operations regarding the impact to health authority regulators as well as interpretation and application of GMPs. Interpersonal skills in verbal and written communications, collaboration, teamwork, negotiation, and conflict resolution.

Preferred

Experience and Skills:

Leadership of cross-functional teams and problem-solving situations. Technical knowledge or proficiency in one or more elements of validation, facilities, equipment, utilities, automation, systems, unit operations in various product modalities, or associated technologies. A combination of experiences foundational to knowledge of validation - in product or process development, engineering, scale-up, manufacturing, technical operations, technology transfer,…