Manager Quality Assurance

SUMMARY:

The Quality Assurance Manager- leads a team of quality professionals that provide quality oversight, GMP guidance and support and make quality related decisions for the designated functional areas within the Sharp Commercial sites. Responsibilities include but are not limited to the supervision of quality activities, assessment for new and ongoing projects, provide direction for cGMPs to direct reports and make recommendations on resolutions and/or path forward for quality related issues. The Quality Assurance Manager is responsible for ensuring all customers receive the appropriate level of quality support and partnership. The QA Manager and their team will work closely with customers on a routine basis and the QA Manager will serve as the first level of escalation for all customer issues or concerns.

The scope of the position includes Allentown, Macungie and/or Conshohocken. The impact of decisions relating to customer interface, quality issues and documentation requirements could expose the company to significant risk or economic loss.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The following is a list of minimum responsibilities for the QA Manager. Other duties may also be assigned:

• Directly supervise the work activities of employees engaged in quality related tasks on the floor to ensure that products and processes meet customers, company, and regulatory requirements/standards.
• Participate in internal, regulatory and customer audits at the discretion of management.
• Review and investigate nonconformances and complaints as needed.
• Create, review and revise SOPs on a designated basis to ensure accuracy.
• Assist in appropriate problem-solving initiatives to address customer or regulatory quality issues as requested by senior management.
• Effectively communicate a variety of personnel actions, e.g., employment, termination, performance and salary reviews, disciplinary actions, scheduling and/or approving overtime.
• Represent Sharp Quality Operations as the main point of contact / SME for customer meetings and calls.
• Support training department to identify new opportunities for training program.
• Serve as the alternate for the Head of Quality during he/her absences.
• Summarize data, draw conclusions, and turn recommendations into clear communications to be distributed to all levels of the organization.
• Support the manufacturing team to ensure the compliance of processes and products and ensure testing and inspection meet all requirements.
• Track and monitor internal and customer KPIs related to quality control and implement programs designed to increase employee’s awareness and knowledge of product nonconformities.
• Assure efficient and economical utilization of materials and continuous improvement of methods to eliminate wasteful practices within the department.
• Identify and implement quality system improvements when gaps are identified through audits, investigations, and departmental reviews.
• Responsible for training, development, motivating and counseling of subordinate staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.
• Work with the team of training specialists to develop processes and best practices for building, managing, and continually improving GMP training program for new and existing staff according to cGMP’s and in alignment with Sharp’s Global Training Standard.
  
  

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.

SUPERVISORY RESPONSIBILITIES:

Direct supervision of quality professionals at the local site. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:

• Bachelor’s degree in science is preferred with five to seven years of related experience or Associate’s degree with seven to ten years of related experience or a minimum of ten years’ related experience.
• Knowledge of current FDA regulations and current industry practice.
• Thorough knowledge of quality and/or operations required.
• Knowledge of DEA regulations desired.
• Broad knowledge of current pharmaceutical industry including packaging practices.
• Above average written and oral communication skills required.
• Above average organizational and planning skills required.
• Knowledge of statistical concepts, methods, and software (knowledge of Minitab is a plus).
• Strong data gathering and analytical skills using statistical software.
• Strong root cause analysis skills, and the ability to apply rigorous structured problem-solving techniques.
  
  

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 handle or write and to speak and 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 and routinely go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions.

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.