Senior Manager, Quality Assurance

SUMMARY:

The Senior Manager of QA leads one or more QA teams supporting designated functional areas of Packaging Operations or Central functions (i.e., Facilities, Warehouse, Project and Account Management, Engineering, IT, Incoming Inspection and Documentation) in a contract pharmaceutical packaging facility.  The position provides quality oversight, regulatory and cGMP guidance to designated areas within Sharp US Commercial Sites.  Responsibilities include, but are not limited to, supervision of quality related activities, troubleshooting quality related issues, making quality decisions regarding issue resolution, and driving continuous quality improvements.  This position is responsible for ongoing contact with customer QA representatives regarding quality non-conformances, investigations, change controls, CAPAs, documents, quality metrics, customer quarterly business reviews, audits and audit follow-up related to their designated functional areas. This position is responsible to assist the Sharp audit team and help prepare area owners to lead discussions and tours relevant to their designated areas during customer and/or regulatory agency inspections and work with internal partners to lead and/or drive subsequent actions.  The Senior Manager Quality is responsible to ensure both internal and external customers receive the appropriate level of quality support and will serve as the second level of escalation for 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 related to the Senior Manager QA position. Other duties may also be assigned.

• Leads one or more QA teams associated with designated functional areas of Packaging Operations or Central functions (i.e., Facilities, Engineering, Warehouse, Packaging Services, Incoming Inspection, Documentation, etc.)
• Responsible for ensuring products and processes meet customer, company and regulatory requirements/standards and participating in internal, regulatory and customer audits as required.

• Responsible for delivering internal and customer quality KPIs and standards for assigned areas.   

• Responsible for leading and coaching teams through problem-solving initiatives and impact assessments associated with change management and non-conformances as well as the review and approval of quality related documentation. 
• Serve as an escalation point for customers and serve as backup for the site Quality lead during absences.
• Summarize data, draw conclusions, and turn recommendations into clear actions which can be effectively communicated across all levels of the organization.
• Identify and lead implementation of continuous improvement opportunities of broader impact (i.e., site or division level).
• Support designated area to ensure compliance to processes and products and ensure testing, inspection and monitoring programs meet all requirements.
• Responsible for implementation of initiatives related to quality systems gap resolutions as well as quality improvements.
• Responsible for contributing to and driving attainment of the short- and long-term quality strategy by understanding the future needs, relative to the required skills and resources needed, to successfully support the business.
• Responsible to work across the broader quality organization to meet future needs through succession planning, training, development and mentoring of personnel.
• Responsible to effectively communicate a variety of personnel actions, including but not limited to, employment, termination, performance, discipline, scheduling, and salary review.

• Performs other related duties as required. by management.

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

SUPERVISORY RESPONSIBILITIES:

Direct supervision of quality managers and 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 seven to ten years of related experience or Associate’s degree with ten to fifteen years of related experience or a minimum of fifteen years of 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.

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

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 accommodations 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.

Approximately 5-10 percent auto travel between sites.

Travel to customers 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.