Associate Director, Quality Operations - 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 six technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; Oligonucleotides 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.

Responsible for the Site Quality Assurance Operational Unit, including main Customer Program QA Point of Contact, Deviation and CAPA Management, Batch Record Release & Review, and Shop Floor QA Oversight.

The head of QA Operations is responsible for leading, developing, and engaging the Site QA Operations Team to ensure successful customer project delivery.

Provides leadership for the Quality Operations in accordance with directions from the Director of Quality Assurance and Control based on the organization's policies, applicable laws, and guidance.

Quality and compliance activities to include the direction of all related operations pertaining to release activities (QA), and continuous improvement (including inspection readiness for all manufacturing and operational areas).

The Associate Director is responsible for ensuring that adequate resources are retained, trained, qualified, validated, and deployed timely to ensure compliant material is released per site schedules.

Ensures cGMP throughout the product life cycle is maintained and compliant with company quality and compliance policies, and practices based on applicable regulation and guidance.

Responsibilities include goal alignment with the Director of Quality Assurance and Control. Goal realization includes achievement consistent with site strategy, developing employees; planning, assigning, and managing work; and continuous improvement, addressing complaints and resolving problems.

Participates directly in customer and government quality audits and inquiries from a quality operational perspective; meaning in regard to material production, deviation resolutions, risk documentation, and release decisions.

Designee to Corden Pharma Colorado's (CPC) site Leadership Team.

Designee to the site Quality Council.

Inspection Readiness

Responsible for ensuring functional site cGMP Inspection Readiness Programs are established in the product life cycle and executed in collaboration with business unit. Ensure allocation of the necessary site resources to successfully execute the program in all functions across the site.

Product Quality Management

Responsible for Product Quality Management activities to include change management, investigation and CAPA management, product field performance (complaint management), and product performance trending, and reporting for site consistent with customer quality agreements. Direct and participate in site level continuous improvement initiatives related to operational impacts, including their quality and regulatory requirements. Manage and drive operational unity Quality metrics within the site to SOP requirements, expectations, and goals. Ensure timely reporting of metrics and remediation plans are in place where metrics do not meet target.

Budgeting and Financial Performance

Accountable for operational budget and financial performance of the site Quality Operations Organization.

Include the following. Other duties may be assigned.

• Quality Risk Management

Responsible for end-to-end Operational Quality Risk Management, where the role ensures unacceptable risk levels are escalated, and therefore not compartmentalized in a product program or area of their responsibility. This includes proactive management of Quality Operations at the site where risk tools are used to baseline and continuously measure the site risk profile by evaluating individual programs and support systems. Ensure risks are managed to ensure our right to operate and quality supply of product to patients

• GMP Surveillance and Education

Notify site, executive management; and customers of significant quality, or regulatory investigations, or issues through appropriate reports, or process

• Organization and Resources

Establish operational Quality objectives and goals for the site based on baselines, operational intelligence, and regulatory requirements. Manage and administer the people processes for personnel in their organization related to the employee lifecycle. This includes the selection and training of personnel on company and local policies and processes. Ensure staff receives appropriate knowledge and skill development

Provides guidance and leadership for the department. Contributes to the direction and oversight of the operational aspects of Corden Pharma Colorado by advising the site Operating Committee.

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 from college or university; and 10 years of related experience; or equivalent combination of education and experience.

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.

Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent, and to draw and interpret bar graphs.

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 sit; work with hands; and talk or hear. The employee is occasionally required to stand; walk; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include 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, and noise typical of an office environment.

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.

• Leadership and deep knowledge of the concepts (above described as responsibilities)
• Governance and decision making regarding regulatory compliance and operational knowledge of API manufacture
• Effective in prioritizing workloads, resolution of issues based on compliance, and scientifically documented risk
• Excellent customer service skills
• Business acumen to drive successful customer experience while meeting business targets from a Quality perspective
• Good written and oral communication skills
• Computer skills with intermediate ability to use Microsoft Office Suite
• Strong planning, implementation, and follow-up skills
• Good facilitation skills and ability to interact with colleagues from all levels of the organization
• High analytical capabilities

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