QA Manager of GMP Systems and Compliance

CordenPharma Colorado
Colorado (US)
Job #0720
Full-time

CordenPharma Colorado
Job #0720

Boulder, Colorado (US)
Full-time

CordenPharma Colorado

CordenPharma Colorado is a highly sophisticated and entrepreneurial mid-sized pharmaceutical manufacturing company located in Boulder, Colorado. Our chemists and engineers are widely recognized for their history of innovation, having developed efficient manufacturing processes for some of the world’s most complex pharmaceutical compounds. CordenPharma Colorado also is acclaimed for its flexible manufacturing facilities and experienced workforce that can handle a wide range of production techniques and volumes. Ultimately, in partnership with our customers, CordenPharma Colorado is focused on its health care mission, proudly producing medicines that help patients around the globe survive and enjoy more comfortable lives.

SUMMARY

Provides management of compliance activities for site Quality operations in accordance with policies, procedures and global standards. Responsible for supervising the responsibilities of GMP Systems, managing regulatory, corporate, internal and external inspections and audits, supplier management and vendor approval, contractor management, documentation control, and training. .

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.
Other duties may be assigned.

  • >> Plan and direct the implementation and maintenance of the Quality systems.
  • >> Manage processes centered around Quality Documentation, Training, Contractor Management, and GMP Compliance functions.
  • >> Manage and perform Quality audits and follow up.
  • >> Manage the supplier qualification program.
  • >> Manage Regulatory inspections and customer audits.
  • >> Manage the internal and external audit program.
  • >> Participate in the review of product release/rejection.
  • >> Develop, maintain and implement the quality systems to ensure product reliability, quality, efficacy, compliance to applicable SOPs, GMP regulations.
  • >> Independent review and approval of deviation and investigation documentation. This includes thorough evaluation of the root cause and the ability to effectively communicate the evaluation to individuals in the science and manufacturing departments.
  • >> Communicate directly with department heads, subject matter experts and suppliers relating to quality matters.
  • >> Effectively work with other departments to streamline and improve systems.
  • >>Stay abreast of regulatory updates and guidance to ensure compliant processes and procedures.

LEADERSHIP & BUDGET RESPONSIBILITIES

Manage a team of employees.  Carry out managerial 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. Produce annual financial budgets, monitor costs/expenses against budget and make adjustments as necessary to avoid budget overruns.

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all of their knowledge, training, ability and experience.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • >> Advanced knowledge of regulatory GMP requirements.
  • >> Strong knowledge of regulations and standards including but not limited to FDA regulations for commercial and clinical products, EMA, and ICH.
  • >> Requires the ability to apply scientific knowledge and understanding of the industry regulations to applicable internal/external issues.
  • >> Excellent written and verbal communication skills.
  • >> Proven abilities in leadership and personnel management.
  • >> Ability to multi-task and help to prioritize the activities of the department appropriately.
  • >> Strong process improvement skills in cross functional teams.
  • >> Excellent accountability, high attention to detail, and strong organizational skills.

EDUCATION and/or EXPERIENCE

  • >> Bachelor degree in a related field
  • >> Minimum of 4 years Quality experience in the pharmaceutical and/or biotechnology industry and 3 years in Quality/Compliance with auditing responsibilities.

LANGUAGE SKILLS

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.  Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.  Ability to write speeches and articles for publication that conform to prescribed style and format.  Ability to effectively present information to top management, public groups, Regulatory agencies, and/or boards of directors.

MATHEMATICAL SKILLS

Competence in scientific mathematical skills and statistics including metric analysis, trending, and reporting.

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

CERTIFICATES, LICENSES, REGISTRATIONS

None

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.

While performing the duties of this job, the employee is regularly required to talk or hear.  The employee frequently is required to stand, walk and sit.  The employee is occasionally required to work with hands; reach above shoulder height; climb or balance; and stoop, kneel, crouch, or crawl.  The employee must occasionally lift and/or move up to 50 pounds.  Specific vision abilities required by this job include close vision, distance vision, color 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 occasionally exposed to wet and/or humid conditions, moving mechanical parts, and outside weather conditions.  The noise level in the work environment is usually moderate.

CORE COMPETENCIES

These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.

  • >> Knowledge of current Good Manufacturing Practices, ICH Guidelines, internal procedures, and other pertinent national and international regulations
  • >> Excellent, Verbal, writing, interpretive, presentation, and interpersonal skills
  • >> Conflict resolution skills
  • >> Excellent customer service skills
  • >> Proactive approach to problem solving and resolution
  • >> Ability to provide leadership in all aspects of QA/Commercial processes.
  • >> Practical and theoretical knowledge of the basic principle of validation and their applications
  • >> Ability to influence
  • >> Analytical skills with the ability to function in an interactive interdisciplinary team environment

SALARY

This is an exempt position. Salary based upon the successful candidate’s qualifications and level of experience.

Application

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Job #0720 – QA Manager of GMP Systems and Compliance

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