Manager, Quality Assurance Product Labeling

Quality Assurance Waltham, Massachusetts


Description

Our QA team is growing exponentially and we're seeking a talented and experienced Manager, QA Product Labeling- to oversee the execution of the processes related to the development of and modifications to,  the Company’s product labeling. In this role, you'll ensure changes to product labeling are properly documented and justified.  You'll help Apellis and your colleagues, help millions who suffer from diseases that are not currently treatable. 

Work closely with a variety of departments to identify product labeling requirements that meet global regulatory requirements and Company timelines in an effective and efficient manner. You'll evaluate policies and procedures for cross-functional and global harmonization.  And you'll plan, organize and prioritize work activities, setting clear and attainable goals and objectives. Develop realistic and effective plans of action that communicate and coordinate product labeling and documentation approvals to those that need to know.

This Manager is expected to effectively interact with internal multidisciplinary team members, CROs and external contract packaging/labeling/distributors and other service providers, to support commercial and clinical trials globally.  In this critical role, you'll ensure that our product labeling release process meets all written procedures and global regulatory requirements. You'll also have operational oversight, which includes review and approval of label proofs, pre and post executed Batch Records for all phases of development and commercial timelines.

Responsibilities:

  • Creation of and modification to product labeling,  by following internal procedures and ensuring labeling content is compliant with global regulatory requirements;
  • Coordinate product labeling review and approvals;
  • Aide in development and documentation of business processes to support product labeling;
  • Participate in audit related activities, gap assessments, and response/mitigation activities;
  • Represent the labeling team as necessary as the SME in cross-functional project team meetings;
  • Manage key internal and external partnerships, including internal customers and contract service providers;
  • Assess new clinical programs for Product Labeling requirements;
  • Other duties as required.

Accountabilities:

  • Identify and communicate quality or compliance risks associated with Product labeling and determine appropriate plan(s) to address risks;
  • Develop, implement and maintain business processes and SOPs supporting Product labeling;
  • Work with the Program Teams to develop and maintain Product labeling for clinical trials with appropriate risk assessment and mitigation to track and oversee development and execution of Product labeling;
  • Oversee review and approval of Product labeling;.
  • Assure Quality Management is informed of any potential compliance issue(s) with Product labeling and other labeling service providers;
  • Participate and/or oversee the disposition of Product labeling and finished good.
  • Gladly help Apellis reach their key milestones to launch these incredible drugs.

Education, Registration & Certification:

BA/BS in any Life Science discipline is required with 5+ years’ in pharmaceutical and some medical devices

Experience:

5+ years of direct Product Labeling experience in regulated industry (pharma/biotech and medical device)

Skills, Knowledge & Abilities:

Strong knowledge of cGMP regulations, practices and trends pertaining to pharmaceutical product development, manufacturing, testing, and clinical operations

Judgment - Exhibits sound and accurate judgment; supports and explains reasoning for decisions, includes appropriate people in decision-making process, makes timely decisions

Technical Skills - Pursues training and development opportunities, strives to continuously build knowledge and skills, shares expertise with others and displays willingness to make tough decisions

Quality Values - Demonstrates accuracy and thoroughness, looks for ways to improve and promote quality, carefully monitors work for accuracy, and also applies comprehensive knowledge of quality and GMP principles so as to maintain current understanding of global GMP regulations

Dependability - Follows instructions, responds to management direction, keeps commitments, completes tasks on time and commits to long hours of work when necessary to achieve goals

Multitasking - Ability to handle multiple tasks concurrently and in a timely fashion.

Team - Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.

Oral Communication - speaks clearly and persuasively in all situations, good listener and responds well to questions

Written Communication - Writes clearly and informatively and able to read and interpret written information and ability to communicate effectively with peers and management

Ethics - Keeps commitments, inspires trust, works with integrity and upholds Quality values.

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 and bend or stand on a stool as necessary.

This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!  Visit http://apellis.com/careerbenefits.html to learn more.

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 pneumocononiosis or any other characteristic protected under applicable federal, state or local law.