JOB SUMMARY
Oversees the work of compliance staff and participates in the work activitiesrelated to audits, policies and procedures, and other projects as determined.Responsible for performing and coordinating the completion of annual departmentaudits/reviews, maintains statistics, historical stats and trends and providesa summary of results to upper management. Ensures applicable department policy& procedure manual and forms are maintained and current.
ESSENTIAL DUTIES ANDRESPONSIBILITIES
Performs annual audits/reviews to ensure compliance with internal policy andprocedures and external control certifications.
Manages the work of Compliance staff responsible for internal audit/reviews,Service Organization Control requirements, and department policies andprocedures. Responsible for training, development, and performance evaluationsof direct reports.
Monitors/creates audit templates, audit calendar and progress, and assignsresources ensuring timely delivery of audit results to department leadership.
Maintains departmental policies & procedures manual and forms. Reviews andapproves updates prepared by staff to ensure accuracy and completeness.
Drafts communication updates of policy changes and results of reviews fordistribution to all department employees.
Coordinates annual Service Organization Control document requests, ensuringthey are delivered to auditors in an organized, complete and timely manner.
Acts as a Compliance resource for process improvement projects and teams onmatters related to department policies and procedures.
Other duties as assigned.
SUPERVISORYRESPONSIBILITIES
Provides formal supervision to individual employees within single functional oroperational area. Recommends staff recruitment, selection, promotion,advancement, corrective action and termination. Plans and monitors appropriatestaffing levels and utilization of labor, including overtime. Prepares anddelivers performance appraisal for staff. Mentors and coaches team members tofurther develop competencies. Leads by example and models behaviors that areconsistent with the company's values
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.
EDUCATION and EXPERIENCE
Bachelor's degree in Biology, Microbiology, Chemistry, or Engineering; or equivalent related work experience. Minimum 5+ years related work experience required. Previous experience within a quality organization preferred. Specialized training in quality assurance audits preferred. Previous supervisory experience a plus.
CERTIFICATES and/or LICENSES
FDA, ISO, or similar quality assurance audit related certification preferred. Must have appropriate license and/or certification where required by law. Green or Black Belt Six Sigma Certification preferred.
COMMUNICATION SKILLS
Ability to comprehend, analyze, and interpret the most complex business documents. Ability to respond effectively to the most sensitive issues. Ability to write reports, manuals, speeches and articles using distinctive style. Ability to make effective and persuasive presentations on complex topics to employees, clients, top management and/or public groups. Ability to motivate and negotiate effectively with key employees, top management, and client groups to take desired action.
Comfortable meeting and engaging with new people.
Warm and engaging demeanor. Ability to assess circumstances, empathize and offer help.
FINANCIAL KNOWLEDGE
Requires in-depth knowledge of financial terms and principles. Ability to calculate complex figures. Ability to forecast and prepare budgets. Conducts financial/business analysis including the preparation of reports.
REASONING ABILITY
Ability to solve advanced problems and deal with a variety of options in complex situations. Requires expert level analytical and quantitative skills with proven experience in developing strategic solutions for a growing matrix-based multi-industry sales environment. Draws upon the analysis of others and makes recommendations that have a direct impact on the company.
OTHER SKILLS and ABILITIES
Experience with Desktop publishing, Microsoft Office Suite and Online Help. Previous experience with SAP, Trackwise, Regulus, and/or CMMS systems.
Knowledge or formal training with lean manufacturing, Six Sigma, 5S programs (among others) preferred.
Knowledge of training and qualification programs preferred.
Experience and knowledge of Quality and Compliance Systems within Life Science Environment(s) a plus.
Quality auditing experience a plus.
SCOPE OF RESPONSIBILITY
Decisions made with in-depth understanding and interpretation of procedures, company policies and business practices to achieve general results. Responsible for setting department deadlines. Errors in judgment may cause long-term impact to co-workers, supervisor, department and/or line of business.
