Position Summary:
The Associate Director, Quality Control is responsible for overseeing and managing the quality control operations to ensure compliance with GMP and regulatory standards. This role involves driving continuous improvement initiatives, and will develop, execute, and periodically evaluate QC practice and processes to ensure that QC operations are efficient, timely, and safeguard data integrity.
The role will author, review and/or approve QC documents such as test methods, SOPs, validation protocol/reports, reference standard qualification protocols/reports, stability protocols/ reports, quality records and investigations (deviations, change controls, CAPAs), regulatory filings, specifications/justification of specifications, and APQR. In addition, this role will develop and validate new microbiological testing methods as needed and investigate and resolve any microbiological quality issues or deviations.
Key Responsibilities Include:
- Work with Director of QC to lead, mentor and develop QC team to foster a culture of quality, accountability and continuous improvement, and to ensure QC systems, procedures and documentation in compliance with GMP, applicable regulatory requirements (FDA, EMA and others), and company policies.
- Lead, review and approve QC data, deviations, change controls, out-of-specification (OOS)/out-of-trend (OOT) investigations, and corrective/preventive actions (CAPAs).
- Identify, develop and implement process improvement initiatives to enhance operational efficiency, accuracy and compliance.
- Oversee the day-to-day activities related to release and stability testing of key intermediates, drug substance and drug product lots at contract testing labs, including generation of CoA’s for product disposition.
- Oversee and manage the stability program to ensure timely testing, data review and trending.
- Oversee QC aspects of method optimization, method validation and transfer, reference standard qualification, etc. as needed.
- Communicate quality related issues to the management in a timely manner.
- Author, review and/or approve QC related documents such as quality agreements, SOPs, test methods, validation protocols and reports, stability protocols/reports, specification documents, and APQR and manage operational aspects as needed for QC related documents.
- Participate in testing lab audits and contribute to regulatory submissions as needed.
- Support group budget planning to ensure expenses align with approved budget.
Education, Registration & Certification:
- Bachelor’s degree or higher in chemistry, biochemistry or a related life science field.
Experience:
- 8+ years of relevant industry experience in a GMP QC environment, including experience working on commercial products.
Skills, Knowledge & Abilities:
- Experience in QC device desirable.
- Proficiency in cGMP, FDA/EMA regulations, ICH guidelines, and relevant analytical techniques.
- Strong knowledge and understanding of QC microbiological requirements, techniques and methodologies.
- Flexible and agile with the ability to pivot quickly to changing circumstances and business needs.
- Excellent leadership, problem-solving and decision-making abilities.
- Strong communication and interpersonal skills.
Physical Demands and Work Environment:
- This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
Travel Requirements:
- Up to 20% travel expected.
Benefits and Perks:
Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more! Visit https://apellis.com/careers/benefits/ to learn more.
Company Background:
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.
For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn
EEO Statement:
Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity 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, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.
For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.