QA Manager of Commercial Products

CordenPharma Colorado
Colorado (US)
Job #1950
Full-time

CordenPharma Colorado
Job #1950

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

This role is to develop, establish and enforce cGMP standards and measures for manufacturing of commercial drug substance within the organization. Assures consistent quality of products by developing and enforcing cGMP systems. Acts as a catalyst for change and improvement in quality systems and performance through benchmarking and proposing project and resource deployment. Oversee the quality aspects of process validation, equipment qualification and facilities for the manufacturing of commercial products. Serves as a resource for all quality related commercial customer relations. Represents the highest level of cGMP understanding and accomplishment.

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

  • >>  Provides cGMP compliance leadership to all departments.
  • >>  Coordinates and serves as back up contact on all customer and government regulatory audits.
  • >>  Analyzes and evaluates information concerning factors such as business situations, production capabilities, manufacturing problems, economic trends, and design and development of new products when making decisions affecting product quality.
  • >>  Develops and issues communications and reports to customers as required, including Annual Process Reviews. Is able to communicate real-time quality information on all ongoing manufacturing activities to upper management as well as customers.
  • >>  Responsible for batch release of commercial products.
  • >>  Review and approval of cleaning documentation.
  • >>  Manages team of QA personnel ensuring all aspects of commercial projects are met from a QA perspective.
  • >>  Assures that manufacturing processes, packaging and testing comply with all customer, Good Manufacturing Practices and Corden SOPs to ensure favorable quality inspections and customer satisfaction.
  • >>  Review and approve master procedures and change controls.
  • >>  Quality leader back up for all validation and qualification programs for customer commercial products.
  • >>  Responsible for the customer complaint and investigation program, Deviation and CAPA Management along with KPI reporting.
  • >>  Serves as liaison between management, customers, and other personnel in formulating and establishing company policies, operating procedures, and goals.
  • >>  Responsible for change control as it relates to commercial products.
  • >>  Develops and delivers presentations to internal and external audiences.
  • >>  Reviews technical publications, articles, and abstracts to stay abreast of technical and compliance requirements in industry.
  • >>  Serves as a backup in support for all quality related functions including quality development and regulatory activities.

LEADERSHIP & BUDGET RESPONSIBILITIES

Manages a team of 1 to 10 employees. Carries 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. Produces annual financial budgets, monitors costs/expenses against budget and makes 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.

EDUCATION and/or EXPERIENCE

Four-year college or university program certificate in chemistry, biochemistry, or related scientific field and 8 years’ experience in pharmaceutical industry or a combination of pharmaceutical industry and academic experience.

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.
  • >>  Good knowledge of peptide chemistry, small molecule synthetic chemistry, analytical chemistry, and pharmaceutical manufacturing.
  • >>  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

To apply, please click on the “Apply Here” button. An email box will open to forward a copy of your resume to our Human Resources department for review. Please include the job number and title in the subject line:

Job #1950 – QA Manager of Commercial Products

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