Curia Hiring for Associate Director, Quality Assurance at Burlington, Massachusetts Full Time

Position overview

The Associate Director, Quality Assurance, with guidance from the site Head of Quality Operations, is responsible for helping lead the quality assurance program at the site, constantly bringing new developments in regulations and industry best practices to Curia quality assurance program. Establish and maintain a risk-based and science-based quality system to protect the public health and to meet Curia’s business needs.

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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

Supervisory responsibilities

This position does have supervisory responsibilities.

Essential job duties

• Establish and maintain a risk-based and science-based quality system to protect the public health and to meet Curia’s business needs

• Through a quality system approach, ensure compliance in GMP operations, while maintaining an efficient workflow to facilitate the operational excellence

• Provide leadership and management within the department through a structural process of objective setting, performance appraisal, and individual development as appropriate. By improving individual performance and group collaboration, the Associate Director will be responsible for improving the overall department productivity and efficiency

• Provide oversight for the site quality assurance program. This includes overseeing and assisting with the site training and auditing programs, as well as the review of SOPs, investigations, specifications, methods, validation reports, and analytical reports

• Along with the QA associates, be responsible for the review and release or rejection Incoming Material

• Prepare, review, and approve external and internal reports and other documentation required by regulatory agencies, customers, or to support the quality assurance function

• Provide oversight over Deviations, Change Controls and CAPA’s and ensure on-time closure

• Support lot disposition to maintain disposition cycle times

• Act as the site representative during regulatory agencies and customer inspections

• Identify and lead operational excellence initiatives, both in the department and site wide, which result in the overall improvement in both areas

• Partner with colleagues in other departments to increase the overall effectiveness of the site performance

• Audit the internal facilities, as well as subcontractors, and outside calibration organizations.

• Act as a quality liaison with current and potential clients, attend meetings and provide input and guidance on quality tasks

• Publish weekly, monthly and quarterly leading indicator metrics to the Site Leadership and above site leadership

• Participate and present at the Quality Management review meetings

• Participate in FMEA’s , gap assessments and drive regulator compliance

• Exhibit safety awareness and safe work practices

  Education, experience, certification and licensures Required

· Bachelor’s degree in Chemistry or related field

· Minimum 8-10 years’ QA/RA experience at USFDA regulated facilities, including 3-5 years’ experience in QA/QC leadership or supervisory role

· USFDA inspection experience

Preferred

· Direct experience leading USFDA inspections

Knowledge, skills and abilities

• Solid knowledge Strong knowledge of regulatory requirements (21 CFR Parts 210, 211, Annex 1)

• Strong strategic thinking skills

• Superior influential and negotiation skills

• Ability to deal compassionately with mistakes of others

• Strong understanding of organizational development

• Demonstrated ability to mentor and coach with the ability to motivate teams to reach a common goal

• Proficient in Microsoft Excel, Word, PowerPoint

• Knowledge of basic quality tools (e.g. pareto charts, histograms, cause-and-effect, root cause analysis)

• Ability to read, analyze and interpret professional journals, technical procedures, and governmental regulations

• Strong written and verbal communication and presentation skills including the ability to independently write develop and write procedures

• Ability to apply the mathematical concepts from algebra and geometry

• Ability to solve problems with a variety of variables using past experience

• Ability to interpret instructions furnished in written, oral, diagram, or schedule form

  Physical requirements

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 accommodations 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 sit; use hands to manipulate, handle, and feel; and able talk and hear. The employee frequently is required to reach with hands and arms. The employee is required to stand; walk; and occasionally required to climb or balance. The employee must occasionally lift and/or move up to 10 pounds.

Work environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually quiet.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.

Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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