QA Group Lead - 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.

The Quality Assurance Group Leader is responsible for providing quality leadership and day to day guidance to Quality Associates, as well as their own individual quality contributions. Represents a high-level of GMP understanding and accomplishment. Responsible for providing strong Quality leadership and GMP/GDP and compliance support for associates and communicates their executional roadblocks to quality management for resolution. Interacts with management in developing department goals and advises management regarding compliance opportunities and advances.

Include the following. Other duties may be assigned.

Provides day to day leadership, coordination, and oversight for Quality Associates in the Quality Assurance Group (see "Leadership Responsibilities" below) in support of pod structures and other quality projects.

Provides quality support for production compliance and documentation:

• Collaborate, review, and approve Change Controls, Standard Operating Procedures (SOPs), and other cGMP documentation as needed
• Review and approve executed cGMP documentation to ensure compliance with internal and regulatory requirements. Resolve comments, as needed, to ensure consistency of review in the Quality organization from the Quality Associate level
• Support final product batch disposition
• Coordinate with Quality Operations for on-floor compliance and documentation support to Manufacturing as needed
• Collaborate, review, and approve minor and major investigations and Corrective Actions Preventative Actions (CAPAs)
• Create, report, and communicate product-related quality metrics to internal stakeholders
• Ensures that Quality Operations Programs comply with all compliance requirements for GMPs as defined by the QMS. Ensures that customer programs, in the execution of related quality agreements, master batch records, and the like are in accord with their requirements including regulatory files, as applicable and available
• Assist in and represent Quality during internal and external audits and regulatory inspections
• Serve as full back-up to QA Product Specialists to collaborate, review, and approve product-related Change Controls, Master Batch Records, Validation Protocols and Reports, Quality Risk Assessments, Annual Product Quality Reviews
• Provide quality input for site compliance and initiatives
• Provide updates (formal and informal) to Management and LT, as needed, regarding compliance, issues/issue resolution, and results

Sets direction and provides templates for documentation and training packages and any other quality documents required to support the site.

Provides leadership to Quality Associates in Quality Assurance: including goal setting; work assignment, planning and prioritization; appraising performance, including rewarding and disciplining; supports personal development and training; addressing complaints and resolving problems; and coaching/mentoring.

Coaches, mentors, and trains Quality personnel on compliance and business issues; encourages excellence by others to operate following Corden's values and through positive feedback for good compliance and teamwork.

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 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.

Bachelor's Degree and 8 years of Quality Assurance experience within the Pharmaceutical Industry; or a combination of Pharmaceutical Industry within a Technical/Operations role and Academic experience. People leadership experience, although not required, is beneficial to this position.

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 publications that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or board of directors.

Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.

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 frequently required to stand, walk, sit, and talk or hear. The employee is occasionally required to work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, 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 moving mechanical parts, fumes or airborne particles, low levels of toxic or caustic chemicals, outside weather conditions, and vibration. 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.

• Excellent customer service skills
• Knowledge of cGMP, cGLP, and FDA regulations, as well as internal Quality related procedures
• Practical and theoretical knowledge of the basic principle of validation and their applications
• Ability to influence
• Excellent verbal, presentation, and written communication skills
• Ability to provide leadership in all aspects of QA processes
• Ability to function in an interactive interdisciplinary team environment
• Proactive approach to problem solving and resolution
• Broad expertise in process improvement methodology
• Demonstrated leadership skills, including coaching and mentoring, and performance management
• Routinely demonstrates a proactive approach to problem identification and resolution
• Understands Corden's business goals and contributes technically to its strategic development
• Demonstrated ability to interact with management in developing project objectives and site strategies; advise management regarding compliance opportunities and advances
• Demonstrated communication skills (presentation, persuasion, written, oral) across all levels of the organization. Prepares clear and well-organized reports on extensive, independent work. Produces entirely self-generated presentations for audiences including upper management, and outside of the site

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