US ~ Boothwyn, PA
Senior Quality Systems Specialist
Our growing and successful business comprises of over 800 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
The Sr. Quality Systems (QS) Specialist is responsible for assuring quality systems at the Philadelphia sites comply with all regulatory requirements and support efficient and effective execution of site-wide GMP activities. This includes the implementation, coordination, and oversight of quality assurance programs that improve product quality, enhance compliance and prevent or minimize risk to the integrity of data. The Sr. QS Specialist ensures the site is audit/inspection ready at all times and collaborates with customers on the planning, coordination, and management of all customer audits for clinical and commercial products. This role also leads negotiations and assures timely execution of customer quality agreements for both clinical and commercial products. The Sr. QS Specialist proactively communicates compliance requirements both internally and, as necessary, to external partners (customers, suppliers), and serves as a role model for the behaviors necessary to maintain compliant GMP practices and advance the quality culture.
Main tasks and responsibilities will include:
- Stay appraised of current regulatory requirements (FDA, EMA, MHRA, PDMA) and expectations. Assure that site quality system procedures remain in compliance and are audit/inspection ready at all times. Identify and implement changes to procedures and practices to enhance compliance and simplify ways of working. Support stakeholders in mitigating quality system gaps.
- Assure all systems, processes, and their outcomes comply with standards that meet applicable national and international regulations and guidelines and fulfil customer and Quotient Sciences requirements.
- Interpret and provide guidance, coaching and mentoring to other functions and, where necessary, customers on regulatory requirements and expectations.
- Represent the site Quality Assurance department as SME in data integrity. Provide routine and specialized data integrity trainings for the Philadelphia sites.
- Lead and participate in internal audits to assess compliance to requirements and identify opportunities for improvements.
- As required, conduct risk assessment of quality systems, including data integrity risks related to both manual and automated systems. Prioritize risks and work with IT, QA, Laboratory, Manufacturing, and Warehouse personnel to mitigate gaps, acting always with an appropriate sense of urgency.
- Review change control requests and assess the impact of changes on quality system, including data integrity, quality agreements, and registrations/product listings. This includes changes to software systems and applications that support manufacturing, warehousing and laboratory. As required, recommend changes to enhance/maintain compliance.
- Responsible for scheduling customer audits and leading all audit preparation activities.
- Responsible for performing walkthroughs of commonly toured areas (i.e. laboratories, manufacturing, warehouse, etc) to ensure audit readiness and communicating any concerns to area leadership for immediate correction.
- Responsible for hosting customer audits, including providing the site opening presentation, coordinating audit logistics, and audit requests. During audits, serve as a subject matter expert on the company’s quality systems and data integrity.
- Responsible for coordination of customer audit responses and tracking of responses to ensure all customer timelines are met.
- Responsible for routine follow-up and oversight of CAPAs generated from customer audits.
- Responsible for generation, coordination, and tracking of all customer quality agreements for clinical and commercial products.
- Ensure that customer quality agreements are negotiated and fully executed in a timely manner to support the business. If customer-provided quality agreement templates are used, assure content is in alignment with Quotient Sciences Global templates and negotiating/resolving any existing conflicts.
- Support timely and thorough completion, review, and approval of investigations into customer complaints, deviations, out-of-specifications and atypical results and provide guidance for issue resolution including CAPAs to minimize potential for issue recurrence, acting always with an appropriate sense of urgency.
- Support general inspection readiness activities at the Philadelphia sites, as required.
- Develop productive, dynamic, professional working relationships founded in trust and respect with company personnel and customers.
- Serve as a champion for a right first-time culture by reviewing and challenging existing processes and driving process improvements.
- Coach and mentor other QA personnel and assure alignment and consistent decision making within the team.
- Perform other duties as assigned.
- Very high concentration of work
- Strict and tight deadlines
- Having to juggle a range of tasks/issues simultaneously
- Working in a hazardous environment with high requirement to follow safety procedures
- Working outside normal working hours
- Needing to respond to client demands
- Bachelor’s degree required in a relevant scientific discipline.
- Minimum eight (8) years’ related experience including strong knowledge in GMP regulations working in a pharmaceutical, biotechnology, or medical device industry.
- Demonstrated experience providing customer-related QA services preferably in a contract services environment.
- Strong subject matter expertise of pharmaceutical quality systems, cGMP requirements, CMC requirements, 21 CFR Part 11, Annex 11, Data Integrity, and Quality by Design (QbD).
- Possess or working towards a Certified Quality Auditor designation or be certified/registered in another recognized/relevant organization (preferred).
- Experience working with quality-related Information technology systems and a fundamental understanding of IT concepts preferred.
- Excellent written and oral communication skills
- Self-directed and strong ability to work effectively across multiple cultures and with cross-functional teams
- Strong interpersonal skills with a special focus on customer satisfaction.
- Effective persuasion and influence skills
- Ability to multi-task and work in a fast-paced environment.
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.