The Senior Director, Quality provides strategic leadership and direction to the Quality Unit (e.g., GMP, GLP) comprising of the Quality Control and Quality Assurance departments. This position is the secondary contact for FDA inspections ensuring company compliance to company policies and procedures, including safety rules and regulations.
(Essential functions, as defined under the Americans with Disabilities Act, may include the following tasks, knowledge, skills and other characteristics. This list of tasks is illustrative ONLY and is not a comprehensive listing of all functions and tasks performed by positions in this class. It does not imply that all positions within the class perform all of the duties listed, nor does it necessarily list all possible duties that may be assigned.)
Responsible for providing strategic leadership, management and direction to the quality unit (e.g., GMP, GLP) of the company and for ensuring that Sr. Management is kept aware of critical issues in the areas of responsibility.
Oversees, manage, coordinate and prioritize the daily activities of the Quality Unit and assigned staff.
Oversee operations of the Quality Unit related to testing and release of products in accordance with all SOPs, cGMPs, company policies and procedures, and FDA requirements related to the Company products.
Carries out managerial responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
Reviews and approves all manufacturing deviations and change control documents in the absence of the Director of Quality Assurance.
Reviews and approves production and process control SOPs that are drafted, reviewed and approved by other organizational units in the absence of the Director of Quality Assurance.
Ensures compliance with and enforcement of SOPs and cGMPs.
Oversees vendor audit and qualification program including contract testing laboratories and raw material manufacturers.
Manages, reviews, and finalizes the completion of inspections and audits to ensure compliance with cGMPs, SOPs, company practices and procedures and governmental regulations with department managers.
Prepares reviews and approves reports for the executive management.
Prepares and manages the department budget, evaluates new equipment and other capital expenditures and submits purchase recommendations.
Oversee, participates and approves the interviewing, hiring and training of department employees; conducts performance evaluations for direct reports; and assists direct reports with performance evaluation process for their units.
Ensure project deadlines and performance standards are established and met.
Review and approve Annual Product Reviews. Ensure compliance with all company policies and procedures, including safety rules and regulations.
Maintains departmental operational budget to ensure completeness, accuracy, and conformance with established procedures, regulations, and organizational objectives.
Experience and 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 experience and qualifications required:
Education
Masters Degree in Chemistry or related life sciences discipline.
Industry Experience Required
Ten (10) years experience in pharmaceutical quality control / assurance and analytical research or a combination thereof.
At least ten (10) years progressive managerial or five (5) years at a Director level or above.
Knowledge, Skills and Abilities:
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, skills and abilities required:
Budgetary Skills
Provide advice and technical assistance in the preparation of annual budgets for specific unit of responsibility.
Ability to outline proposed funding for increases and new initiatives, estimated costs and expenses, and capital expenditures needed for department.
Computer Skills
Advanced knowledge of computers with proficiency in using MS Office, MS Outlook and business software systems commonly used in the pharmaceutical industry such as SAP or similar MRP system.
Must be able to navigate through spreadsheets (excel or access), charts and PowerPoint .
Analytical /Problem Solving Skills
Mastery of concepts, principles and methods to solve difficult or unusual systemic problems characterized by their level of importance and impact to the company. Formulates logical and objective conclusions recognizing alternatives and their implications.
Strong strategic management skills and abilities. Ability to develop new ways of administering business and lead unprecedented projects.
Provide cost-benefit analyses to substantiate decisions in product selection.
Communication Skills
Ability to speak on a one-to-one basis using appropriate vocabulary and grammar to obtain information, explain policies, procedures, and persuade others to accept or adopt a specific opinion or action.
Ability to make presentations to various groups and customers.
Skills in writing concise, logical, grammatically correct analytical reports, policies and procedures, and general office communications.
Must demonstrate a collaborative work style, with a strong ability to build relationships, gain credibility and partner with internal customers and co-workers. Strong organizational, communication and project management skills
Self-Management Skills
Ability to perform a variety of duties often changing from one task to another of a different nature under the stress of frequent interruptions and/or distractions.
Skills in setting priorities accurately to reflect the relative importance of the job in a timely manner.
Innovative skills in organizing materials, information, people in a systematic way to optimize efficiently and minimize duplication of efforts.
Human Relations Skills
Demonstrated skills and abilities in establishing rapport and gaining the trust of others.
Ability to establish and maintain cooperative working relationships.
Ability to organize objectives, delegate responsibilities, train, evaluates subordinates effectiveness and administers necessary discipline.
Working Environment
The working environment demands of this job are physically and environmentally centered on characteristics and abilities involved in this work. The work environment considers the risks and discomforts in the physical surroundings and the nature of the work assigned to ensure that all safety regulations and techniques required to perform the job are precautions practical to eliminate all risks.
Physical
Work is sedentary. No special physical demands required to perform this work.
Environmental
Work is regularly performed inside in an office and manufacturing environment. Requires use of personal protective equipment in designated areas.
The work area involves everyday risks or discomforts requiring normal safety precautions typical of such places as offices, meeting and training rooms, etc. Use of safe work practices with office equipment required.
Work area is adequately lighted, heated and ventilated.
Must exercise extreme safety and precaution at all times in all designated cGMP areas in the facility.
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