Associate Director, Quality Control

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 CoAs 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:

• Bachelors 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 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 follow us onTwitterandLinkedIn

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.