Director, Quality Assurance

Director, Quality Assurance page is loaded Director, Quality Assurance Apply locations Macungie time type Full time posted on Posted 30+ Days Ago job requisition id JR30882 SUMMARY:
The Director, Quality Assurance, is responsible for leading and overseeing the Quality function at a US Commercial Sharp Packaging site. This role involves the development and implementation of quality strategies and processes to ensure compliance with regulatory requirements and internal standards. The Director of Quality will lead the quality assurance team and will collaborate with various internal departments and stakeholders to foster a culture of quality throughout the organization.
As a CDMO, the Quality Assurance Director will collaborate with clients to understand clients’ needs, to report on quality performance and to satisfy them by delivering a consistently high standard of product quality.
This position reports directly to the VP of Quality, US Commercial Packaging.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The following is a list of minimum responsibilities related to the Director, Quality Assurance position. Other duties may also be assigned.
Develop and implement quality policies, systems, processes in compliance with FDA, EMA and other regulatory agencies, as appropriate.
Lead and mentor the Quality team, providing guidance and support to enhance their skills and performance.
Oversee the management of quality audits and regulatory inspections, ensuring that any findings are addressed promptly and effectively.
Oversee a robust batch release process and a comprehensive process for quality oversight of manufacturing and quality control.
Collaborate with R&D, Manufacturing, Quality Control, Technical Operations, Project Management departments to ensure that quality is integrated into all aspects of product development and production.
Monitor and report upon quality metrics, trends and other significant issues, to senior management, providing recommendations for continuous improvement.
Ensure that all quality documentation is maintained accurately and in accordance with regulatory requirements.
Manage risk assessments and develop risk mitigation strategies related to product quality and compliance.
Responsible for coordinating appropriate problem-solving initiatives to address customer or regulatory quality issues.
Stay current on industry trends, regulatory changes, and best practices in quality assurance.
Responsible for coordinating appropriate problem-solving initiatives to address customer or regulatory quality issues.
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Demonstrated knowledge and application of FDA cGMP/GCP regulations, ANSI/ISO/IEC/ASQC standards, and 21 CFR Part 11 in a manufacturing setting
Demonstrated history of team management and effecting cross‐functional change with strong problem solving and interpersonal skills
Excellent verbal and written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non‐technical audience
In depth understanding and experience with quality expectations of facility/ equipment commissioning and qualification
SUPERVISORY RESPONSIBILITIES:
Direct supervision of the quality organization at a US Commercial Sharp Packaging site.
PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:
Bachelor’s degree in Life Sciences, Pharmacy or a related field; advanced degree preferred.
Minimum of 8 years of experience in quality assurance within the bio/ pharmaceutical industry, with at least 5 years in a leadership role.
In-depth knowledge of regulatory requirements and quality management systems (QMS).
Strong analytical and problem-solving skills.
Excellent communication and interpersonal skills, with the ability to influence and collaborate across departments and functions.
Proven track record of managing quality audits and inspections successfully.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel and talk or hear. The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions.
Travel to customers and between sites on an as needed basis.
DISCLAIMER:
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

About Us Sharp Packaging Services works across the world to create unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industry.
We are made up of two dynamic international divisions, Sharp Packaging Solutions and Sharp Clinical Services. Together our 1,600-strong team works from state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands.
We’ve built an exceptional global reputation for the design, serialisation and production of innovative, cost-effective compliance packaging for even the most complex products.
Our extensive range includes blister packs, bottles, pouches and stick packs, but our expertise goes far beyond, enabling us to support your product through every stage of design, development, manufacture and delivery.
Our clinical services division is one of the world’s leading providers of innovative clinical supply chain services, with a talented and highly experienced team that can handle every aspect of your supply chain. Our work spans everything from drug development and manufacturing to clinical supplies packaging, labelling, distribution, Qualified Person auditing and comparator sourcing.

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