The Senior QA Compliance Associate will assume responsibilities associated with the process for the internal/external audit program, investigation, document review and in support of a GMP Quality Management System to ensure compliance to regulatory and internal requirements.  This appointee will be responsible for working closely with Wacker Biotech US Management and Departmental staff in support of the Quality Management System.  This person may support QA operational functions as needed.  This may include document reviews and batch records release.

Essential Functions:

• Provide expertise and guidance to resolve compliance issues as it relates to manufacturing, testing and release of product with all WBU policies and procedures in addition to all federal/state/local/global and pharmaceutical laws and regulations.
• Manage, lead and/or perform root cause analysis for investigations, deviations, CAPA, Change Control and provides metric collection for timely resolutions to events, out of trend events, facilities and document Risk Management activities (e.g. FMEA.)
• Identify and implement improvements to the QA processes and systems
• Author, review and approval of WBU policies, SOPs, risk assessments and validation documents
• Oversee the supplier assessment program including audits, supplier evaluation and supplier agreements.
• Assists with planning and conducting internal/external compliance audits. Follow up on audits to assure that action plans are developed and completed in a timely fashion.
• Evaluates, analyzes and trends quality indicators.  Then prepares reports of quality operations, productivity as well as monthly quality metrics.
• Actively contribute to a culture of continuous capability development through coaching, mentoring and developing team members.
• Support QA operations to release materials and drug substance/drug product.  Including but not limited to data review, batch record review, etc.)

Position Qualifications:

• BA/BS in a scientific discipline with 6+ years’ experience in biotechnology or pharmaceutical industry or MS with 5+ years of experience
• Minimum 5 years’ experience in a regulated industry; Quality Assurance role required
• Ability to travel up to 5%.
• Significant experience and understanding of the requirements of GMP and have the ability to apply knowledge in implementation, monitoring and maintenance to ensure the effectiveness of the GMP QMS
• Through knowledge of FDA and EU regulations, along with GxP documentation and data integrity requirements.
• Support, guide and advise on all aspects of manufacturing, QC and supporting operations within the company as GMP SME.
• Experience in regulatory inspections.
• Must be self-directed and requires an appropriate level of education and experience to make and act upon decisions that impact the site.
• Detail oriented and strong communication skills.
• Ability to work in a high pace environment.
• Critical thinking and problem-solving skills.
• Proficiency in Microsoft Word, including editing, formatting, utilizing templates, creating forms, and embedding hyperlinks, and basic experience and competency with Excel and Adobe Acrobat Professional is a plus.
• Experience in working within document control systems is preferred.
• Experience with Electronic Document and Quality Management Systems preferred
• Work with various user groups to facilitate auditing and training processes.
• Technical writing and problem-solving skills
• Must be able to function under a stressful situation while being able to remain focused at the necessary requirements. In addition, must be able to appropriately identify and escalate issues on a timely basis

The anticipated salary range for candidates who will work in California is $111,000.00-140,000.00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Wacker is a multi-state employer, and this salary range may not reflect positions that work in other states.

• Compensation and Incentive plans
• Medical, Dental, and Vision Insurance effective day 1
• Paid Time Off in addition to personal days and holidays
• Paid parental leave
• Wellbeing fund
• Flexible hybrid work arrangements
• 401(k) with company match
• Education Assistance Program
• Career development and advancement opportunities
• Support for Community Involvement