Manager, Quality Systems Compliance - Boulder, United States - CORDEN PHARMA BOULDER INC

Description

Job Description

Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.

CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people's lives.

Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.

Provides management of compliance activities for the Quality unit in accordance with policies, procedures, and global standards. Responsible for compliance of GMP Systems. Manages the performance of Quality Systems to established key requirements and leading indicators. The QS Compliance Manager ensures that quality and manufacturing intelligence are reported to the Director of Quality Assurance and Control in a frequent manner to ensure compliance and continuous improvement.

Include the following. Other duties may be assigned.

• Implements the site Quality culture and vision through projects as established by the Director of Quality Assurance and Control
• Leads and promotes the Quality culture throughout the site through their interactions and consideration of internal and external customer needs
• Manages the implementation and maintenance of the Quality Systems through collaboration with internal customers and stakeholders
• Manages processes centered on ensuring compliance to all systems under the Quality Unit through metrics and auditing of GMP compliance functions
• Ensures timely response to regulatory inspections and customer audits including the management and implementation of audit CAPAs
• Maintains and implements systems to ensure quality, efficacy, and compliance to applicable SOPs and GMP regulations
• Independent review of QMS areas through audit and review
• Manages and implements all feedback and analysis systems such as quality review boards, site management reviews, and quality system boards
• Communicates directly with department heads, subject matter experts, and suppliers relating to quality matters
• Effectively works with other departments to streamline and improve systems
• Stays informed and communicates to stakeholders and affected departments, of regulatory updates and guidance to ensure processes and procedures are compliant
• Responsible for Site Master File and Quality Manual (as appropriate)

Produce annual financial budgets, monitor costs/expenses against budget, and make adjustments as necessary to avoid budget overruns.

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

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.

• 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 IC
• 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

Ten years Quality experience in the Pharmaceutical and/or Biotechnology industry in Quality Systems and/or Compliance.

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.

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

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

None.

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.

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.

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, written, 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 quality system processes
• Practical and theoretical knowledge of the basic principles of quality systems and their application in an operational environment
• Ability to influence others
• Analytical skills with the ability to function with interdisciplinary teams

Actual pay will be based on your skills and experience.

• 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
• Accident Plan
• Critical Illness Insurance
• Dental Insurance
• Disability Insurance
• Employee Assistance Program
• Flexible Spending Account
• Health Insurance PPO/HSA
• Hospital Indemnity Plan
• ID Theft Protection
• Life Insurance
• Paid Maternity/Paternity Leave
• Tuition Reimbursement
• Wellness Program
• Vacation – Three Weeks 1st Year
• Vision Insurance