Senior Manager/Associate Director of Quality Control - Malvern, United States - Ocugen

Description

Job Details

Job Location: Main Corporate Office - Malvern, PA

Salary Range: Undisclosed

Description

Job Purpose

The Senior Manager/Associate Director of QC is a strategic leadership role responsible for fostering a culture of quality, efficiency, and excellence, ensuring that quality and compliance are integrated into the day-to-day operations and long-term Quality strategy.

The Senior Manager/Associate Director of QC is responsible for ensuring that the organization's production operations, from raw materials to finished products, meet the quality, integrity, and efficiency standards set by the organization. The Senior Manager/Associate Director of QC will develop, implement, and periodically evaluate a program to ensure that the products meet quality, integrity, functionality, and other specifications and requirements.

The Senior Manager/Associate Director of QC will supervise the quality control department and supervisory staff, conduct performance evaluations that are timely and constructive, and handle discipline and termination of employees in accordance with company policy. The Senior Manager/Associate Director r of QC will collaborate with management and senior staff across production departments and roles to draft acceptable quality standards, develop and implement quality standard testing and evaluation processes, and facilitate communication among production divisions and management. The Senior Manager/Associate Director will assess test results and approve recommended changes, review quality control documentation such as checklists, logs, and reports for effectiveness, accuracy, and relevance, and conduct random inspections and quality control checks.

The Senior Manager/Associate Director of QC will periodically report the status of quality control and operations to executive leadership and, when required, regulatory agencies. The Senior Manager/Associate Director of QC will perform other related duties as assigned.

This position requires a broad range of knowledge and experience with quality control, quality assurance and quality system, regulatory compliance, and understanding of the international regulatory landscape for the manufacturing of API, DS and DP across Ocugen's product portfolio.

Duties and Responsibilities

• Developing and implementing quality control procedures and standards and training appropriate staff.
• Ensuring all products meet the required quality standards and comply with relevant regulations. Ensure Good Documentation Practices are followed.
• Oversee that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the pre-analytic, analytic, and post-analytic phases of testing.
• Oversee that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical, and biological hazards.
• Oversee that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills Collaborate with an organization's purchasing manager to ensure raw materials from external suppliers meet quality requirements.
• Collaborating with other departments to ensure that quality control processes are integrated into the quality control testing laboratory and production process.
• Collect, analyze, review, and interpret analytical and manufacturing data. Ensure Good Data Practices are followed.
• Audit manufacturing areas for adherence to company procedures and standards.
• Facilitate completion of improvement initiatives and build capacity within systems and processes that require engagement and consensus across all functional departments.
• Perform root cause analysis of issues and implement successful corrective actions.
• Review and maintain analytical and quality records as applicable procedures and standards require.
• Perform regular safety audits, and exhibit felt leadership.
• Develop, review, and approve quality control plans.
• Ensure quality control laboratory and manufacturing plant are inspection readiness.
• Conduct and document quality control inspections.
• Perform quality checks for the regulatory filing documents.
• Work with upper management to develop and implement strategies for maintaining and improving the overall quality of the company's products.
• Stay updated with industry developments and changes in regulations and guidelines and adapt to the company's quality control processes as needed.
• Collaborate with external partners, such as suppliers and contractors, to ensure they meet the company's quality standards.
• Communicate with customers and other stakeholders about the company's quality control processes and efforts to ensure product quality.

Qualifications

• A minimum of ten years experience within a pharmaceutical company is a must. Previous experience must be a combination of working in a quality control lab and/or manufacturing area. Strong working knowledge of Biologics, Vaccines, and Cell and Gene therapies for GMP manufacturing processes and analytical testing.
• A B.Sc. degree in science is required. M.S. and Ph.D. in science will be considered.
• Experienced in running microbiology, analytical, molecular biology methods, and technologies is required.
• Excellent knowledge of cGMPs, ALCOA++ requirements, 21 CFR Parts 11, 58, 606, 610, and 820, 42 CFR Part 493, including EU, ICH, OECD, HC, WHO, and CLIA regulatory regulations is must.
• Experience in process auditing, quality control, error-proofing, root cause analysis, process improvements, training, and troubleshooting is preferred.
• Strong attention to detail, observation, organizational, and leadership skills are essential.
• In-depth knowledge of QC standards, procedures, mathematics, data analysis, and statistical methods is also necessary.
• Good technical and IT skills, excellent communication and listening skills, and the ability to understand regulatory compliance are also necessary.
• Ability to prepare QC metrics and make a presentation to senior management.
• Proven ability to work independently, collaborate and communicate effectively, and work effectively in a team-oriented environment.
• Attention to detail with an ability to perform critical reviews of various types of documents.
• Ability to influence diverse stakeholders and drive accountability and decision-making cross-functionally.

Working Conditions

This position operates primarily in an office setting and may include 10% of travel.

Physical requirements

This is a largely sedentary role.

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual's conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past,

current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.