Senior Manager Manufacturing Engineering QA

Aktis Oncology•Boston, MA

50d

About The Position

The Sr Manager, Manufacturing Engineering Quality Assurance will be responsible for leadership of the various Quality Assurance (QA) functions associated with GMP Process Engineering and Validation, as well as individual contributions, to establish clinical manufacturing phase appropriate Quality Engineering standards for Aktis Quality Assurance for GMP product manufacture and release. This role is comprised of many specific responsibilities as defined below:

Requirements

Quality operational experience implementing and overseeing investigational drug manufacture and aseptic processing GMP operations in a manufacturing facility.
Demonstrated Quality leadership through a partnership approach with Aktis Facility & CMC Manufacturing to enable high-quality and compliant product production and distribution to patients as required.
Demonstrated experience building and leading exceptional Product GMP Quality Assurance team.
Knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologic and Drug therapy product GMP facilities.
Working knowledge of aseptic practices and clean room design/operations auditing techniques.
Strong leadership skills with the ability to thrive in a high throughput environment.
Ability to lead and manage projects/teams within corporate objectives and project timelines.
Successful in mentoring people managers regarding collaboration, teamwork, conflict management.
BS/BA degree in a scientific or allied health field with 4+ years of relevant work experience, or relevant comparable background in Biologics or Drug product Manufacturing.
Quality Assurance background.
Knowledge of GMP, FDA regulations, and compliance.
Ability to help support the implementation of Quality Management System (QMS).
Exceptional verbal, written, interpersonal, organizational and project management skills.
Excellent organizational and project management skills.
Able to lead and mentor junior/senior staff and cross-functional teams.

Nice To Haves

Biologic or drug product manufacturing and/or aseptic process operations.
A combination of experiences in quality assurance plus operations, laboratory, or related functional roles. Example functional roles include quality operations, quality assurance, quality engineering, manufacturing, process engineering, product development, process development, materials management, supply chain management, quality control, analytical development, CMC regulatory affairs, equipment, or facilities management.
Diverse experiences in a GMP environment including, but not limited to, batch production record review, or approval, ancillary batch related control records, standard operating procedures, work instructions, facility/equipment/utilities deviations, change control, corrective actions, preventive actions, out of specification results, validation plans or protocols, equipment qualification, audits, electronic inventory systems, quality management systems.
The ability to identify, focus, and solve problems in a timely and efficient manner.
Experience with quality audits and FDA regulatory inspections.
Experience or working knowledge of R&D or clinical supply areas and processes.
Radiopharmaceutical background/experience a plus.

Responsibilities

Responsible for GMP facility utilities design review and qualification.
Primary driver and overseer for manufacturing deviation investigations and product disposition decisions regarding environmental impact on product quality.
Responsible for manufacturing clean room / aseptic process qualification.
Provide quality oversight to GMP facility maintenance and calibration programs
Drives GMP facility environmental monitoring and qualification.
Manage all GMP facility manufacturing monitoring and alarm systems qualification.
Oversee all GMP equipment qualification and equipment deviation investigations and resulting outcome with regards to specific batch of radiopharmaceutical product, as well as possible impact to all product batch manufacture, past and future.
Oversee Quality of all GMP process validation.
Non-conformance of GMP facility temperature-controlled areas qualification and drive investigators and approvals on such system investigation.
Ensure manufacturing site compliance with current U.S. and EU cGMP regulations and industry standards as defined by Aktis Quality System.
Oversee GMP facility change control events, assuring proper consideration of potential impact to product quality and assuring process is executed per Aktis Change Control system, giving final approval to product change.
Provide Quality Engineering oversight of modification and construction review and approvals for Aktis GMP manufacturing space.
Provide leadership to staff by directing, mentoring, coaching and developing them towards professional growth, enhanced job performance and career satisfaction.
Provide input for continuous improvement of company's quality systems.
Identify quality issues/discrepancies, and effectively and proactively resolve them in a diplomatic, flexible and constructive manner.
Oversee all Quality aspects of technology transfer of product manufacturing and control systems to external third-party contract or internal manufacturing site.
Manage GMP responsibilities for all in-house GMP site engineering.
Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality systems, regulatory, etc., at all levels.
Establish, educate, and enforce standard operating procedures required under GMP.
Lead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions.
Identify performance or compliance gaps and implement or propose solutions.
Maintain a state of readiness for and participate in audits and inspections of Aktis' in-house GMP manufacturing space and associated utilities.
Manage complexities within a product development environment to plan, organize, execute, monitor staff assignments and all activities necessary to achieve continuous clinical and commercial supply.