QA Documentation and Change Control Business Lead

Bayer • Myerstown, PA

3d

About The Position

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
QA Documentation and Change Control Business Lead
Using the DSO (Dynamic Shared Ownership) and VACC (Visionary, Architect, Catalyst and Coach) Principles, this role requires building, coaching and guiding teams. The incumbent operates as a change agent driving innovation, continuous improvement, efficiency gains, waste elimination, cost savings and budget adherence. Robust processes are to be strategically created and maintained for inspection readiness, corporate/global compliance and quality processing, while minimizing risks.
Quality oversight, approval authority, and project creation/participation/management will be required within the department and for the site, as applicable.
Strong written and oral communications skills with local and global customers are key to building effective and influential relationships.
The incumbent assumes responsibility for the quality of documentation and change control functions, coaching a team of exempt and non-exempt personnel.

Requirements

• B.S. or B.A. Degree in science is required. Education in Chemistry, Biology, Pharmacy, Microbiology.
• 8+ years demonstrated leadership experience in a regulatory industry or GMP laboratory setting.
• Personal computer skills
• Knowledge, practical application, and understanding of the sciences are necessary to perform certain functions of this position, as well as scheduling, follow-up, and problem-solving skills.
• A working knowledge of GMPs and pharmaceutical standards
• Demonstrated ability to work in a team-oriented environment and good communication skills.
• Demonstrated ability to take initiative and a willingness to learn and stay abreast of current standards.
• Demonstrated ability to be self-motivated and develop critical judgments, as disposition decisions affect production schedules and products getting to the marketplace.
• Demonstrated ability to meet customer needs.

Nice To Haves

• 2 years of supervisory/leadership experience
• Completion of a rotational assignment
• In lieu of combined experience and education listed above, a master’s degree and 4 yrs experience in a regulatory industry or laboratory setting including 2 years of demonstrated leadership experience, or PhD and 2 yrs of demonstrated leadership experience in a regulatory industry or laboratory setting, may be considered.

Responsibilities

• Directly coach QA staff responsible for the preparation of master production documents (master packaging orders, batch manufacturing records, testing monographs, primary packaging specifications, SAP-QM master data, APR etc.).
• Interface with the United States Pharmacopoeia (USP) on compendia-related topics.
• Support Bayer U.S. by review of proposed and implemented changes to United States Pharmacopoeia and National Formulary (USP-NF) and communicate to the Bayer Corporation Compendial Network.
• Initiate, review, support, and approve change management process related to master production documents, documents with registration requirements, technical and site changes.
• Support change management processes for all production operations performed at MYT.
• Support site projects, and assist in validation, qualification, and risk assessments.
• Directly coach QA staff responsible for the release of packaging components, raw materials and work-in-process materials supporting the daily operations of the Myerstown site.
• Oversee Myerstown (MYT) finished goods release and support investigations related to materials released by QA-MYT.
• Provide QA oversight into the laboratory retesting requirements and ensure that the activities performed by the production departments are within compliance.
• Manages exempt and non-exempt employees who are responsible for master production document preparation. This includes master packaging orders, MES master batch records, batch manufacturing records (paper-based), primary packaging specifications, laboratory testing monographs, APRs and maintenance of SAP-QM and other system-relevant QA master data.
• Interfaces for Myerstown site with USP on compendial questions.
• Reviews proposed and implemented changes to USP-NF for all of Bayer US and reports to Bayer Corporation Compendial Network.
• Supports change management for master document changes and regulatory related changes.

Benefits

• health care
• vision
• dental
• retirement
• PTO
• sick leave

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees